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    Clinical Trial Results:
    A prospective, randomized, verum controlled, open label, parallel group multi-center phase III clinical trial to demonstrate the superiority of 500 or 250 mg Aspirin® i.v. (BAY 81-8781) treatment versus 300 mg Aspirin® N tablets p.o. (BAY e4465A) in patients with Acute Coronary Syndrome, measured by time dependent thromboxane inhibition

    Summary
    EudraCT number
    2007-005163-94
    Trial protocol
    DE  
    Global end of trial date
    01 Jul 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    24 Jul 2016
    First version publication date
    10 Jul 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY81-8781/12946
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00910065
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser Wilhelm Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate superiority of 500 milligram (mg) and 250 mg Aspirin® intravenous (IV) (BAY81-8781) treatment over oral treatment with 300 mg Aspirin® N tablets to inhibit thromboxane A2-release (measured as stable metabolite thromboxane B2 in serum [TXB2]) at 5 minutes after single dose of study drug administration.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    18 Mar 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 270
    Worldwide total number of subjects
    270
    EEA total number of subjects
    270
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    166
    From 65 to 84 years
    96
    85 years and over
    8

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Of 273 subjects enrolled, 270 subjects were randomized and treated, and the remaining 3 subjects were screen failures.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
    Arm description
    Single IV dose of aspirin at a dose of 500 mg on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    BAY81-8781
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV dose of aspirin at a dose of 500 mg as bolus infusion injection in approximately 30 seconds through the vein on Day 1.

    Arm title
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Arm description
    Single IV dose of aspirin at a dose of 250 mg on Day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    BAY81-8781
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single IV dose of aspirin at a dose of 250 mg as bolus infusion injection in approximately 30 seconds through the vein on Day 1.

    Arm title
    Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Arm description
    Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.
    Arm type
    Active comparator

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    BAYe4465
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.

    Number of subjects in period 1
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Started
    88
    85
    97
    Completed
    84
    83
    91
    Not completed
    4
    2
    6
         Consent withdrawn by subject
    1
    1
    3
         Death
    2
    -
    1
         Lost to follow-up
    -
    1
    1
         Missing
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
    Reporting group description
    Single IV dose of aspirin at a dose of 500 mg on Day 1.

    Reporting group title
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Reporting group description
    Single IV dose of aspirin at a dose of 250 mg on Day 1.

    Reporting group title
    Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Reporting group description
    Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.

    Reporting group values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet Total
    Number of subjects
    88 85 97 270
    Age categorical
    Units: Subjects
    Age continuous
    Calculated age at enrolment.
    Units: years
        arithmetic mean (standard deviation)
    60.5 ± 13 58.6 ± 14.1 61.4 ± 14.3 -
    Gender categorical
    Units: Subjects
        Female
    31 25 40 96
        Male
    57 60 57 174
    Smoking
    Units: Subjects
        Non-smoker
    31 27 36 94
        Passive smoker
    0 0 1 1
        Past or present smoker
    57 58 60 175
    Current alcohol consumption
    Units: Subjects
        Missing
    0 0 1 1
        Abstinent
    26 23 29 78
        Light alcohol consumption
    48 46 53 147
        Moderate alcohol consumption
    14 16 14 44
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    83.84 ± 18.93 86.67 ± 18.66 82.64 ± 18.85 -
    Height
    Units: centimeter (cm)
        arithmetic mean (standard deviation)
    172.2 ± 10.55 174.49 ± 10.55 170.51 ± 9.28 -
    Body mass index
    Units: kilogram per square meter (kg/m^2)
        arithmetic mean (standard deviation)
    28.21 ± 5.65 28.4 ± 5.18 28.21 ± 4.79 -

    End points

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    End points reporting groups
    Reporting group title
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
    Reporting group description
    Single IV dose of aspirin at a dose of 500 mg on Day 1.

    Reporting group title
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Reporting group description
    Single IV dose of aspirin at a dose of 250 mg on Day 1.

    Reporting group title
    Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Reporting group description
    Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety analysis set (N=270) included all subjects who were randomized and received study treatment after randomization.

    Subject analysis set title
    Pharmacodynamic (PD) analysis set
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    PD analysis set (N=263) included all subjects valid for safety analysis who have a valid TXB2 measurement at baseline and at 5 minutes after study drug administration.

    Primary: Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose

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    End point title
    Concentration of Thromboxane B2 (TXB2) at 5 Minutes Post-dose
    End point description
    Values below lower limit of quantitation (LLOQ) were substituted by half of the corresponding LLOQ for the calculation of statistics. Since there was no single LLOQ value and dependent on the measurement batch, LLOQ was not specified and the LLOQ values were used in the calculations. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    End point type
    Primary
    End point timeframe
    5 minutes post-dose
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    86 [1]
    82 [2]
    95 [3]
    Units: nanogram per milliliter
        geometric mean (geometric coefficient of variation)
    3.1 ± 364.85
    3.86 ± 580.41
    223.74 ± 724.37
    Notes
    [1] - PD analysis set
    [2] - PD analysis set
    [3] - PD analysis set
    Statistical analysis title
    Aspirin 250 mg IV / 300 mg tablet
    Statistical analysis description
    Geometric means were compared using analysis of covariance (ANCOVA) models: baseline TXB2 values as covariate and use of concomitant treatment affecting the measurement up to the 5 minutes blood sample (yes/no), stratification by ST segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI)/unstable angina pectoris (UAP) at randomization as factors. Ratio of geometric means was obtained by exponentiating the differences in respective least squares (LS) mean estimates from the model.
    Comparison groups
    Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [4]
    Method
    ANCOVA
    Parameter type
    Ratio of geometric means
    Point estimate
    0.018
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.011
         upper limit
    0.03
    Notes
    [4] - One-sided P-value
    Statistical analysis title
    Aspirin 500 mg IV / 300 mg tablet
    Statistical analysis description
    Geometric means were compared using ANCOVA models: baseline TXB2 values as covariate and use of concomitant treatment affecting the measurement up to the 5 minutes blood sample (yes/no), stratification by STEMI and NSTEMI/UAP at randomization as factors. Ratio of geometric means was obtained by exponentiating the differences in respective LS-mean estimates from the model.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [5]
    Method
    ANCOVA
    Parameter type
    Ratio of geometric means
    Point estimate
    0.014
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.009
         upper limit
    0.023
    Notes
    [5] - One-sided P-value
    Statistical analysis title
    Aspirin 500 mg IV / 250 mg IV
    Statistical analysis description
    Geometric means were compared using ANCOVA models: baseline TXB2 values as covariate and use of concomitant treatment affecting the measurement up to the 5 minutes blood sample (yes/no), stratification by STEMI and NSTEMI/UAP at randomization as factors. Ratio of geometric means was obtained by exponentiating the differences in respective LS-mean estimates from the model.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.21 [6]
    Method
    ANCOVA
    Parameter type
    Ratio of geometric means
    Point estimate
    0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.47
         upper limit
    1.37
    Notes
    [6] - One-sided P-value

    Secondary: Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose

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    End point title
    Concentration of Thromboxane B2 (TXB2) at 20 Minutes Post-dose
    End point description
    Values below LLOQ were substituted by half of the corresponding LLOQ for the calculation of statistics. Since there was no single LLOQ value and dependent on the measurement batch, LLOQ was not specified and the LLOQ values were used in the calculations. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
    End point type
    Secondary
    End point timeframe
    20 minutes post-dose
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    86 [7]
    82 [8]
    95 [9]
    Units: nanogram per milliliter
        geometric mean (geometric coefficient of variation)
    1.48 ± 260.06
    2.08 ± 534.77
    14.64 ± 3664.2
    Notes
    [7] - PD analysis set
    [8] - PD analysis set
    [9] - PD analysis set
    Statistical analysis title
    Aspirin 250 mg IV / 300 mg tablet
    Statistical analysis description
    Geometric means were compared using ANCOVA models: baseline TXB2 values as covariate and use of concomitant treatment affecting the measurement up to the 20 minutes blood sample (yes/no), stratification by STEMI and NSTEMI/UAP at randomization as factors. Ratio of geometric means was obtained by exponentiating the differences in respective LS-mean estimates from the model.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    177
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [10]
    Method
    ANCOVA
    Parameter type
    Ratio of geometric means
    Point estimate
    0.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.073
         upper limit
    0.27
    Notes
    [10] - One-sided P-value
    Statistical analysis title
    Aspirin 500 mg IV / 300 mg tablet
    Statistical analysis description
    Geometric means were compared using ANCOVA models: baseline TXB2 values as covariate and use of concomitant treatment affecting the measurement up to the 20 minutes blood sample (yes/no), stratification by STEMI and NSTEMI/UAP at randomization as factors. Ratio of geometric means was obtained by exponentiating the differences in respective LS-mean estimates from the model.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    181
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [11]
    Method
    ANCOVA
    Parameter type
    Ratio of geometric means
    Point estimate
    0.099
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.054
         upper limit
    0.18
    Notes
    [11] - One-sided P-value
    Statistical analysis title
    Aspirin 500 mg IV / 250 mg IV
    Statistical analysis description
    Geometric means were compared using ANCOVA models: baseline TXB2 values as covariate and use of concomitant treatment affecting the measurement up to the 20 minutes blood sample (yes/no), stratification by STEMI and NSTEMI/UAP at randomization as factors. Ratio of geometric means was obtained by exponentiating the differences in respective LS-mean estimates from the model.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
    Number of subjects included in analysis
    168
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.087 [12]
    Method
    ANCOVA
    Parameter type
    Ratio of geometric means
    Point estimate
    0.71
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.44
         upper limit
    1.16
    Notes
    [12] - One-sided P-value

    Secondary: Platelet Aggregation Inhibition (PAI) at 5 Minutes and 20 Minutes After Single Dose of Study Drug Administration Measured as Response to Treatment

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    End point title
    Platelet Aggregation Inhibition (PAI) at 5 Minutes and 20 Minutes After Single Dose of Study Drug Administration Measured as Response to Treatment
    End point description
    Percentage inhibition for platelet aggregation was assessed. In the categories listed below, 'N' signifies the number of subjects evaluable for the timepoints.
    End point type
    Secondary
    End point timeframe
    5 and 20 minutes post-dose
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    86 [13]
    82 [14]
    95 [15]
    Units: percentage (%) inhibition
    arithmetic mean (standard deviation)
        5 minutes post-dose (N=86, 81, 94)
    20.6 ± 12.1
    23 ± 19
    75.6 ± 38.5
        20 minutes post-dose (N=86, 82, 94)
    22.1 ± 13.4
    21.6 ± 13
    42.5 ± 34.1
    Notes
    [13] - PD analysis set
    [14] - PD analysis set
    [15] - PD analysis set
    No statistical analyses for this end point

    Secondary: Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose

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    End point title
    Serum Concentration of Prostacyclin Metabolite at 5 and 20 Minutes Post-dose
    End point description
    Serum concentrations of prostacyclin metabolite, that is 6-Keto Prostaglandin F1 ALPHA (6-KETO-PGF1ALPHA) at 5 and 20 minutes post-dose, were reported. In the categories listed below, 'N' signifies the number of subjects evaluable for the timepoints.
    End point type
    Secondary
    End point timeframe
    5 and 20 minutes post-dose
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    86 [16]
    82 [17]
    95 [18]
    Units: picogram per milliliter
    arithmetic mean (standard deviation)
        5 minutes post-dose (N=84, 80, 94)
    227.2 ± 321.7
    243.4 ± 259
    657.5 ± 808.8
        20 minutes post-dose (N=85, 81, 93)
    199.5 ± 272.8
    208.3 ± 270.6
    364 ± 450.1
    Notes
    [16] - PD analysis set
    [17] - PD analysis set
    [18] - PD analysis set
    No statistical analyses for this end point

    Secondary: Incidence of the Composite Clinical Endpoint of Cardiovascular Death, Stroke and Myocardial Infarction up to Day 30 After Single Dose of Study Drug Administration

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    End point title
    Incidence of the Composite Clinical Endpoint of Cardiovascular Death, Stroke and Myocardial Infarction up to Day 30 After Single Dose of Study Drug Administration
    End point description
    The occurrence of myocardial re/infarction (MI) was assessed up to and including the 30-day time point. Serial electrocardiograms (ECGs), creatine kinase (CKs) and/or creatine kinase-muscle-brains (CK-MBs) plus/minus (+/-) 2 hours*3 were obtained for each suspected recurrent ischemic event. Ischemic stroke (IS) is defined as a new, sudden focal neurological deficit resulting from a presumed cerebrovascular cause that is not reversible or results in death within 24 hours and is not due to a readily identifiable cause, such as a tumor or seizure. Composite number of subjects with cardiovascular (CV) death, IS and MI was reported.
    End point type
    Secondary
    End point timeframe
    Post-randomization up to 30 days after single dose of study drug administration
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    88 [19]
    85 [20]
    97 [21]
    Units: Subjects
    2
    0
    3
    Notes
    [19] - Safety analysis set
    [20] - Safety analysis set
    [21] - Safety analysis set
    Statistical analysis title
    Aspirin 500 mg IV-300 mg tablet
    Statistical analysis description
    Differences in incidences and their 2-sided 95% confidence intervals (CI) and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.74 [22]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.3
         upper limit
    3.8
    Notes
    [22] - P-value for test of difference
    Statistical analysis title
    Aspirin 250 mg IV-300 mg tablet
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.075 [23]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.2
         upper limit
    0.3
    Notes
    [23] - P-value for test of difference
    Statistical analysis title
    Aspirin 500 mg IV-250 mg IV
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.17 [24]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    2.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    5.6
    Notes
    [24] - P-value for test of difference

    Secondary: Incidence of Post-randomization Deaths From all Causes, Cardiovascular Deaths, Myocardial Re/Infarctions and Ischemic Strokes Within 24 Hours, 7 Days And 30 Days After Single Dose of Study Drug Administration

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    End point title
    Incidence of Post-randomization Deaths From all Causes, Cardiovascular Deaths, Myocardial Re/Infarctions and Ischemic Strokes Within 24 Hours, 7 Days And 30 Days After Single Dose of Study Drug Administration
    End point description
    The occurrence of MI was assessed up to and including the 30-day time point. Serial ECGs, CKs and/or CK-MBs, +/-2 hours*3 were obtained for each suspected recurrent ischemic event. IS is defined as a new, sudden focal neurological deficit resulting from a presumed cerebrovascular cause that is not reversible or results in death within 24 hours and is not due to a readily identifiable cause, such as a tumor or seizure. All deaths were considered CV in nature unless a non-CV cause was clearly shown. Number of subjects with deaths from all causes, CV deaths, MI and IS was reported.
    End point type
    Secondary
    End point timeframe
    Post-randomization up to 24 hours, 7 days and 30 days after single dose of study drug administration
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    88 [25]
    85 [26]
    97 [27]
    Units: Subjects
        Deaths from all causes up to 24 hours
    1
    0
    0
        Deaths from all causes up to 7 days
    1
    0
    1
        Deaths from all causes up to 30 days
    2
    0
    1
        Cardiovascular deaths up to 24 hours
    1
    0
    0
        Cardiovascular deaths up to 7 days
    1
    0
    1
        Cardiovascular deaths up to 30 days
    1
    0
    1
        Myocardial re/infarction up to 24 hours
    1
    0
    0
        Myocardial re/infarction up to 7 days
    1
    0
    1
        Myocardial re/infarction up to 30 days
    1
    0
    1
        Ischemic strokes up to 24 hours
    0
    0
    1
        Ischemic strokes up to 7 days
    1
    0
    1
        Ischemic strokes up to 30 days
    1
    0
    1
    Notes
    [25] - Safety analysis set
    [26] - Safety analysis set
    [27] - Safety analysis set
    Statistical analysis title
    500 mg IV-300 mg tablet: all deaths up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35 [28]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.5
    Notes
    [28] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: all deaths up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.92 [29]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    3
    Notes
    [29] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: all deaths up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.48 [30]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.3
         upper limit
    4.9
    Notes
    [30] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: all deaths up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1 [31]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    1.3
    Notes
    [31] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: all deaths up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35 [32]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    1
    Notes
    [32] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: all deaths up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35 [33]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    1
    Notes
    [33] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: all deaths up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [34]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.6
    Notes
    [34] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: all deaths up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [35]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.6
    Notes
    [35] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: all deaths up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.17 [36]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    2.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    5.6
    Notes
    [36] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: CV deaths up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35 [37]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.5
    Notes
    [37] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: CV deaths up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.92 [38]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    3
    Notes
    [38] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: CV deaths up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.92 [39]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    3
    Notes
    [39] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: CV deaths up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1 [40]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    1.3
    Notes
    [40] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: CV deaths up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35 [41]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    1
    Notes
    [41] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: CV deaths up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35 [42]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    1
    Notes
    [42] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: CV deaths up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [43]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.6
    Notes
    [43] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: CV deaths up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [44]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.6
    Notes
    [44] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: CV deaths up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [45]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.6
    Notes
    [45] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: MI events up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35 [46]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.5
    Notes
    [46] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: MI events up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.92 [47]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    3
    Notes
    [47] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: MI events up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.92 [48]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    3
    Notes
    [48] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: MI events up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1 [49]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    1.3
    Notes
    [49] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: MI events up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35 [50]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    1
    Notes
    [50] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: MI events up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.35 [51]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    1
    Notes
    [51] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: MI events up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [52]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.6
    Notes
    [52] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: MI events up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [53]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.6
    Notes
    [53] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: MI events up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [54]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.6
    Notes
    [54] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: IS events up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [55]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    1.2
    Notes
    [55] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: IS events up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.95 [56]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    3.2
    Notes
    [56] - P-value for test of difference
    Statistical analysis title
    500 mg IV-300 mg tablet: IS events up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    185
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.95 [57]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    3.2
    Notes
    [57] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: IS events up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [58]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.3
         upper limit
    1.2
    Notes
    [58] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: IS events up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [59]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.3
         upper limit
    1.2
    Notes
    [59] - P-value for test of difference
    Statistical analysis title
    250 mg IV-300 mg tablet: IS events up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects included in analysis
    182
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [60]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    -1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.3
         upper limit
    1.2
    Notes
    [60] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: IS events up to 24 hours
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 1 [61]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.4
         upper limit
    1.4
    Notes
    [61] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: IS events up to 7 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [62]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.6
    Notes
    [62] - P-value for test of difference
    Statistical analysis title
    500 mg IV-250 mg IV: IS events up to 30 days
    Statistical analysis description
    Differences in incidences and their 2-sided 95% CI and p-values were calculated by stratified Mantel-Haenszel method (strata: STEMI and NSTEMI/UAP). In case of zero event in a treatment group, the correction term 0.1 (correction type: group size) was applied. The study was not powered to show statistically significant differences between the treatment groups. Consequently, these analyses are regarded as exploratory analyses.
    Comparison groups
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV v D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Number of subjects included in analysis
    173
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.36 [63]
    Method
    Mantel-Haenszel
    Parameter type
    % of absolute risk difference
    Point estimate
    1.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.3
         upper limit
    3.6
    Notes
    [63] - P-value for test of difference

    Other pre-specified: Number of Subjects with Treatment-emergent High Laboratory Abnormalities

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    End point title
    Number of Subjects with Treatment-emergent High Laboratory Abnormalities
    End point description
    Treatment-emergent events were defined as events started or worsened up to 24 hours after single dose of study drug administration. Number of subjects with at least one high laboratory assessment after start of treatment was reported. The laboratory variables were as follows: 1. Clinical chemistry laboratory variables included CK-MB, CK, creatinine, glucose, potassium, aspartate transaminase (AST), alanine transaminase (ALT), sodium, Troponin I, Troponin T; 2. Coagulation laboratory variables included prothrombin time (PT) quick method, international ratio of PT (PT-INR), partial thromboplastin time (PTT); 3. Hematology laboratory variables included hematocrit, hemoglobin, platelets, red blood cells, white blood cells.
    End point type
    Other pre-specified
    End point timeframe
    Up to 24 hours on Day 2
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    88 [64]
    85 [65]
    97 [66]
    Units: Subjects
        CK-MB
    3
    6
    4
        CK
    6
    7
    5
        Creatinine
    4
    3
    4
        Glucose
    19
    17
    19
        Potassium
    2
    2
    1
        AST
    3
    7
    6
        ALT
    1
    4
    2
        Sodium
    2
    2
    2
        Troponin I
    1
    3
    0
        Troponin T
    6
    3
    3
        PT quick method
    2
    2
    1
        PT-INR
    1
    2
    1
        PTT
    11
    7
    6
        Hematocrit
    0
    1
    1
        Hemoglobin
    2
    1
    0
        Platelets
    1
    1
    2
        Red blood cells
    1
    1
    1
        White blood cells
    5
    5
    5
    Notes
    [64] - Safety analysis set
    [65] - Safety analysis set
    [66] - Safety analysis set
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Vital Signs at the End of Treatment (Day 2): Heart Rate

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    End point title
    Change From Baseline in Vital Signs at the End of Treatment (Day 2): Heart Rate
    End point description
    Heart rate was assessed at screening (Day 1) and at Day 2, and was measured in supine position if possible. Screening was defined as baseline for this endpoint. In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Day 1) and Day 2
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    88 [67]
    85 [68]
    97 [69]
    Units: beats per minute
    arithmetic mean (standard deviation)
        Baseline (N=88, 85, 97)
    74.5 ± 14
    77.1 ± 20.4
    76.3 ± 15.7
        Change at Day 2 (N=83, 81, 91)
    -1.4 ± 11.8
    -3.6 ± 21.1
    -3.4 ± 15.9
    Notes
    [67] - Safety analysis set
    [68] - Safety analysis set
    [69] - Safety analysis set
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Vital Signs at the End of Treatment (Day 2): Blood Pressure

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    End point title
    Change From Baseline in Vital Signs at the End of Treatment (Day 2): Blood Pressure
    End point description
    Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at screening (Day 1) and at Day 2, and were measured in supine position if possible. Screening was defined as baseline for this endpoint. In the categories listed below, “N” signifies the number of subjects evaluable for the timepoints.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Day 1) and Day 2
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    88 [70]
    85 [71]
    97 [72]
    Units: millimeter of mercury (mmHg)
    arithmetic mean (standard deviation)
        SBP at baseline (N=88, 85, 97)
    140.1 ± 20.3
    137.7 ± 23.8
    142.2 ± 20.4
        Change in SBP at Day 2 (N=83, 81, 90)
    -10.5 ± 19.8
    -10.4 ± 23.3
    -12.4 ± 20.5
        DBP at baseline (N=88, 85, 97)
    82.2 ± 13.8
    78.6 ± 12.5
    80.7 ± 12.1
        Change in DBP at Day 2 (N=83, 81, 90)
    -8 ± 13.4
    -6 ± 13.6
    -3.8 ± 12.5
    Notes
    [70] - Safety analysis set
    [71] - Safety analysis set
    [72] - Safety analysis set
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Abnormal Electrocardiogram (ECG) Findings

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    End point title
    Number of Subjects With Abnormal Electrocardiogram (ECG) Findings
    End point description
    ECG was performed at screening (Day 1) and at Day 2, and findings were considered 'abnormal' as per the Investigator's discretion. Screening was defined as baseline for this endpoint.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Day 1) and Day 2
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    88 [73]
    85 [74]
    97 [75]
    Units: Subjects
        Baseline (Day 1)
    88
    85
    97
        Day 2
    80
    78
    81
    Notes
    [73] - Safety analysis set
    [74] - Safety analysis set
    [75] - Safety analysis set
    No statistical analyses for this end point

    Other pre-specified: Incidence of all Post-randomization Strokes of Unknown Etiology Until 24 Hours (Treatment-emergent), and Within 7 Days After Single Dose of Study Drug Administration

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    End point title
    Incidence of all Post-randomization Strokes of Unknown Etiology Until 24 Hours (Treatment-emergent), and Within 7 Days After Single Dose of Study Drug Administration
    End point description
    Treatment-emergent events were defined as events started or worsened up to 24 hours after single dose of study drug administration. IS is defined as a new, sudden focal neurological deficit resulting from a presumed cerebrovascular cause that is not reversible or results in death within 24 hours and is not due to a readily identifiable cause, such as a tumor or seizure. Number of subjects with post-randomization IS events of unknown etiology was reported.
    End point type
    Other pre-specified
    End point timeframe
    Post-randomization up to 24 hours and 7 days after single dose of study drug administration
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    88 [76]
    85 [77]
    97 [78]
    Units: Subjects
        Up to 24 hours
    0
    0
    0
        Up to 7 days
    0
    0
    1
    Notes
    [76] - Safety analysis set
    [77] - Safety analysis set
    [78] - Safety analysis set
    No statistical analyses for this end point

    Other pre-specified: Incidence of Composite of Post-randomization Thrombolysis in MI (TIMI) Major and Minor Bleeding, and Bleeding Requiring Medical Attention up to 24 Hours After Single Dose of Study Drug Administration

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    End point title
    Incidence of Composite of Post-randomization Thrombolysis in MI (TIMI) Major and Minor Bleeding, and Bleeding Requiring Medical Attention up to 24 Hours After Single Dose of Study Drug Administration
    End point description
    TIMI classification for bleedings was as follows: Major: Intracranial hemorrhage; or spontaneous, bleeding at any instrumented site, retroperitoneal, or clinically significant overt hemorrhage associated with a drop in hematocrit of at least 15% or a drop in hemoglobin of at least 5 grams per deciliter (g/dL); Minor: Clinically overt bleeding (examples: gross hematuria or hematemesis) associated with a drop in hematocrit of 9% to less than or equal to (<=) 15% or a drop in hemoglobin of 3 g/dL to <=5 g/dL; Minimal: Any clinically overt sign of hemorrhage (including imaging) associated with a fall in hemoglobin less than (<) 3 g/dL (or, when hemoglobin is not available, a fall in hematocrit of <9%). Bleeding requiring medical attention was defined as TIMI minimal bleeding or bleeding which was not classified above and required medical or surgical treatment. Composite number of subjects with TIMI major and minor bleeding, and bleeding requiring medical attention was reported.
    End point type
    Other pre-specified
    End point timeframe
    Post-randomization up to 24 hours after single dose of study drug administration
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    88 [79]
    85 [80]
    97 [81]
    Units: Subjects
    6
    3
    6
    Notes
    [79] - Safety analysis set
    [80] - Safety analysis set
    [81] - Safety analysis set
    No statistical analyses for this end point

    Other pre-specified: Hospital Mortality During the Hospitalization for Acute Coronary Syndrome

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    End point title
    Hospital Mortality During the Hospitalization for Acute Coronary Syndrome
    End point description
    Number of subjects with hospital mortality during the hospitalization period for acute coronary syndrome was reported.
    End point type
    Other pre-specified
    End point timeframe
    During hospital stay
    End point values
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Number of subjects analysed
    88 [82]
    85 [83]
    97 [84]
    Units: Subjects
    2
    0
    1
    Notes
    [82] - Safety analysis set
    [83] - Safety analysis set
    [84] - Safety analysis set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent events including bleedings are defined as events started or worsened up to 24 hours after single dose of study drug administration.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV
    Reporting group description
    Single IV dose of aspirin at a dose of 500 mg on Day 1.

    Reporting group title
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV
    Reporting group description
    Single IV dose of aspirin at a dose of 250 mg on Day 1.

    Reporting group title
    Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Reporting group description
    Single oral dose of aspirin tablet at a dose of 300 mg on Day 1.

    Serious adverse events
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 85 (1.18%)
    3 / 97 (3.09%)
         number of deaths (all causes)
    2
    0
    1
         number of deaths resulting from adverse events
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden cardiac death
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 500 mg IV D,L-lysine acetylsalicylate (Aspirin, BAY81-8781) 250 mg IV Acetylsalicylic acid (Aspirin, BAYe4465) 300 mg Tablet
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 88 (18.18%)
    10 / 85 (11.76%)
    20 / 97 (20.62%)
    Vascular disorders
    Arteriovenous fistula
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Haematoma
         subjects affected / exposed
    3 / 88 (3.41%)
    3 / 85 (3.53%)
    3 / 97 (3.09%)
         occurrences all number
    3
    3
    3
    Hypertension
         subjects affected / exposed
    2 / 88 (2.27%)
    1 / 85 (1.18%)
    3 / 97 (3.09%)
         occurrences all number
    2
    1
    3
    Hypertensive crisis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Arterial haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Surgical and medical procedures
    Stent placement
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    1 / 97 (1.03%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Injection site haematoma
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Chest pain
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Vessel puncture site haemorrhage
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 85 (1.18%)
    0 / 97 (0.00%)
         occurrences all number
    1
    1
    0
    Pleural effusion
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Disorientation
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Investigations
    High density lipoprotein decreased
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 88 (0.00%)
    2 / 85 (2.35%)
    0 / 97 (0.00%)
         occurrences all number
    0
    2
    0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Ventricular tachycardia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 85 (2.35%)
    1 / 97 (1.03%)
         occurrences all number
    1
    2
    1
    Intercostal neuralgia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Ascites
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 88 (1.14%)
    2 / 85 (2.35%)
    2 / 97 (2.06%)
         occurrences all number
    1
    2
    2
    Skin and subcutaneous tissue disorders
    Cold sweat
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 97 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    1
    0
    1
    Renal and urinary disorders
    Renal cyst
         subjects affected / exposed
    0 / 88 (0.00%)
    1 / 85 (1.18%)
    0 / 97 (0.00%)
         occurrences all number
    0
    2
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 88 (1.14%)
    1 / 85 (1.18%)
    1 / 97 (1.03%)
         occurrences all number
    1
    1
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 88 (0.00%)
    0 / 85 (0.00%)
    1 / 97 (1.03%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperlipidaemia
         subjects affected / exposed
    1 / 88 (1.14%)
    0 / 85 (0.00%)
    0 / 97 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Apr 2009
    1. Two inclusion criteria were added 2. Secondary efficacy and safety variables were added 3. Subjects were assigned to treatment groups using interactive voice response system (IVRS) 4. Blood samples for TXB2 analysis, serum prostacycline and platelet aggregation inhibition analysis were taken during screening period 5. Cardiovascular endpoints, stroke endpoints and hemorrhagic endpoints were appointed for confirmation by an Endpoint Adjudication Committee 6. The statistical model was ANCOVA for the analysis of the primary efficacy variable (log transformed). The ANCOVA models were stratified by region (China and Europe), by use of anticoagulant and by the stratification factor STEMI/NSTEMI and unstable angina from the randomization.
    03 Aug 2010
    It was decided to cancel the study in China and conduct it only in Germany. For this reason, the coordinating investigator was changed, the number of randomized subjects was reduced, and sample size calculations were modified accordingly. Stratification by region (China and Europe) was excluded from the planned primary and secondary efficacy analyses. Since randomization was no longer performed by Interactive Voice Response System, the method of assigning subjects to treatment was modified. Prior and concomitant medications not approved in Germany were excluded from the list of prior/concomitant therapy permitted for this study. Pregnancy test was excluded since pregnancy testing has not been routinely performed on sites. Central laboratory was not needed anymore for the purpose of the study and all laboratory evaluations were to be performed by the local laboratories. Furthermore, only local ECG performance and evaluations were to be performed. Other relevant changes included the following: 1. Addition of statements regarding none-specific gender distribution and treatment(s) following the end of the study 2.Elaboration of an inclusion criterion by adding a statement on subject’s capacity to consent prior enrollment 3. A new definition of the time between screening and randomization (that is, the time frame was changed from “no more than 2 hours” to “as short as possible”) 4. Definition for sufficiently reliable safety signal of clinical relevance regarding bleeding events was added 5. On study definition and definitions of populations for analysis were slightly modified.
    18 Oct 2011
    1. Change of one inclusion criterion to: Angina pectoris lasting for more than 20 minutes within the last 24 hours before study drug treatment (or equivalent acute symptoms such as increasing dyspnoea, diaphoresis, nausea, abdominal/epigastric pain, syncope, etc.) and at least one of the following: a. ECG changes suggestive for ischemia: ST elevation or T-wave change or ST depression, new or presumed left bundle-branch block, b. Elevated troponin T levels >0.01 nanogram per milliliter or any other elevated troponin levels according to local laboratory reference values, c. Risk factors for acute coronary syndrome such as known coronary artery disease, diabetes mellitus, impaired renal function, peripheral artery or cerebrovascular disease, current smoking. 2. Change of one exclusion criterion to: Stroke within 3 months prior to study drug treatment. 3. Deletion of the following exclusion criterion: Other anticoagulants in the last 5 days before study drug treatment. 4. Addition of the following exclusion criterion: Treatment with glycoprotein IIb/IIIa inhibitors within 48 hours prior to study drug treatment and before the 20 minutes blood samples for thromboxane, prostacyclin, and platelet aggregation measurements had been taken. In addition, an appropriate definition of the PD population for analysis was implemented and “haematology (full blood count)” was excluded from the safety laboratory assessments.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Occurrence of "±” in relation with geometric CV is auto-generated and cannot be deleted. Decimal places were automatically truncated if last decimal equals zero.
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