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    Clinical Trial Results:
    Prospective, randomized and controlled clinical trial comparing i.v. bolus application of Abciximab to i.c.application of Abciximab during primary PCU in patients with acute ST-elevation myocardial infarction

    Summary
    EudraCT number
    		 2007-007864-63
    Trial protocol
    		 DE  
    Global end of trial date
    11 Jun 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Abciximab-STEMI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00712101
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Leipzig
    Sponsor organisation address
    Ritterstr. 26, Leipzig, Germany, 04109
    Public contact
    Dr. Petra Neuhaus, Prof. Dr. Holger Thiele, + 49 (0)34 865-1428, kardiologie.herzzentrum@helios-gesundheit.de
    Scientific contact
    Dr. Petra Neuhaus, Prof. Dr. Holger Thiele, + 49 (0)34 865-1428, kardiologie.herzzentrum@helios-gesundheit.de
    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
    27 May 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Jun 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jun 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus application with respect to 90-day mortality, reinfarction and new congestive heart failure
    Protection of trial subjects
    Patients were closely monitored with regard to safety during the course of the study. In addition to the documentation of adverse events, the following safety parameters were recorded: - Severe or life-threatening bleeding according to the GUSTO definition until the time of hospital discharge - Severe cardiac arrhythmia (ventricular tachycardia, ventricular fibrillation) during administration of the abciximab bolus - Hemodynamic compromise (> 15 mmHg systolic blood pressure drop) during abciximab bolus administration - Infections presumably associated with abciximab administration.
    Background therapy
    		 -
    Evidence for comparator
    		 Adjunctive intravenous abciximab administration is established to improve coronary microcirculationand to reduce major cardiac adverse events in with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).
    Actual start date of recruitment
    16 Jul 2008
    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: 2065
    Worldwide total number of subjects
    2065
    EEA total number of subjects
    2065
    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)
    1120
    From 65 to 84 years
    878
    85 years and over
    67

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between July, 2008, and April, 2011, 2065 patients from 22 German trial sites were enrolled to the AIDA STEMI trial.

    Pre-assignment
    Screening details
    		 Patients were eligible for the study if they are ≥18 years of age and have clinical symptoms of acute myocardial infarction of >30 minutes and <12 hours with specific ECG criteria for STEMI. The inclusion criteria represent the standard definition for STEMI. The exclusion criteria reflect known contraindications for abciximab use.

    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
    		 Abciximab i.c.
    Arm description
    		 Abciximab bolus intracoronary
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abciximab
    Investigational medicinal product code
    B01AC13
    Other name
    ReoPro
    Pharmaceutical forms
    Irrigation solution
    Routes of administration
    Intracoronary use
    Dosage and administration details
    0.25 mg/kg body weight bolus i.c. subsequently 0.125 µg/kg/min body weight i.v. continously with a maximum of 10 µg/kg/min

    Arm title
    		 Abciximab i.v.
    Arm description
    		 Abciximab bolus intravenously
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Abciximab
    Investigational medicinal product code
    B01AC13
    Other name
    ReoPro
    Pharmaceutical forms
    Irrigation solution
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25 mg/kg body weight bolus i.v. subsequently 0.125 µg/kg/min body weight i.v. continously with a maximum of 10 µg/kg/min

    Number of subjects in period 1
    		Abciximab i.c. Abciximab i.v.
    Started
    1032
    1033
    Completed
    940
    936
    Not completed
    92
    97
         Consent withdrawn by subject
    35
    31
         Lost to follow-up
    11
    11
         Protocol deviation
    46
    55

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Abciximab i.c.
    Reporting group description
    		 Abciximab bolus intracoronary

    Reporting group title
    Abciximab i.v.
    Reporting group description
    		 Abciximab bolus intravenously

    Reporting group values
    		 Abciximab i.c. Abciximab i.v. Total
    Number of subjects
    		 1032 1033 2065
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 546 574 1120
        From 65-84 years
    		 455 423 878
        85 years and over
    		 31 36 67
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63 ± 13 63 ± 13 -
    Gender categorical
    Units: Subjects
        Female
    		 256 255 511
        Male
    		 776 778 1554
    Killip class on admission
    Units: Subjects
        Killip 1
    		 854 869 1723
        Killip 2
    		 95 76 171
        Killip 3
    		 29 26 55
        Killip 4
    		 17 26 43
        na
    		 37 36 73
    Infarct-related artery
    Units: Subjects
        Left anterior descending
    		 424 431 855
        Right coronary artery
    		 433 429 862
        Left main
    		 4 7 11
        Bypass graft
    		 2 3 5
        Left circumflex
    		 130 122 252
        na
    		 39 41 80
    TIMI fl ow before PCI
    Units: Subjects
        TIMI 0
    		 587 562 1149
        TIMI I
    		 125 158 283
        TIMI II
    		 154 143 297
        TIMI III
    		 114 110 224
        na
    		 52 60 112
    Cardiovascular risk factors: present smoking
    Units: Subjects
        yes
    		 400 426 826
        no
    		 528 492 1020
        na
    		 104 115 219
    Cardiovascular risk factors: Hypertension
    Units: Subjects
        yes
    		 707 684 1391
        no
    		 276 307 583
        na
    		 49 42 91
    Cardiovascular risk factors: Hypercholesterolaemia
    Units: Subjects
        yes
    		 382 413 795
        no
    		 588 549 1137
        na
    		 62 71 133
    Cardovascular risk factors: Diabetes mellitus
    Units: Subjects
        yes
    		 202 199 401
        no
    		 790 791 1581
        na
    		 40 43 83
    Body-mass index
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 28 ± 4.5 28 ± 4.5 -
    Symptom onset to PCI hospital admission
    Units: minute
        median (inter-quartile range (Q1-Q3))
    		 160 (100 to 285) 166 (101 to 287) -
    Admission-to-balloon-time
    Units: minute
        median (inter-quartile range (Q1-Q3))
    		 32 (22 to 50) 32 (22 to 49) -

    End points

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    End points reporting groups
    Reporting group title
    Abciximab i.c.
    Reporting group description
    		 Abciximab bolus intracoronary

    Reporting group title
    Abciximab i.v.
    Reporting group description
    		 Abciximab bolus intravenously

    Primary: Composite of all-cause death, reinfarction, new congestive heart failure

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    End point title
    		 Composite of all-cause death, reinfarction, new congestive heart failure
    End point description
    Composite of all-cause death, reinfarction, and new congestive heart failure at 90 days after randomization. All components of the combined clinical end point were adjudicated by a Clinical End points Committee (CEC), blinded to the patient's assigned treatment.
    End point type
    Primary
    End point timeframe
    90 days
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    940
    936
    Units: patients
        Patients with event
    66
    71
        Patients without event
    874
    865
    Attachments
    		 Time to composite endpoint
    Statistical analysis title
    		 Primary: composite endpoint at 90 days
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1876
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.66
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.3

    Secondary: Death

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    End point title
    		 Death
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    940
    936
    Units: patients
        dead
    42
    34
        alive
    898
    902
    Attachments
    		 Time to death
    Statistical analysis title
    		 Secondary: death at 90 days
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1876
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.97

    Secondary: Reinfarction

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    End point title
    		 Reinfarction
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    940
    936
    Units: patients
        patients with event
    18
    17
        patients without event
    922
    919
    Attachments
    		 Time to reinfarction
    Statistical analysis title
    		 Secondary: reinfarction at day 90
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1876
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 2.06

    Secondary: Congestive heart failure

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    End point title
    		 Congestive heart failure
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    940
    936
    Units: patients
        patients with event
    23
    38
        patients without event
    917
    898
    Attachments
    		 Time to heart failure
    Statistical analysis title
    		 Secondary: congestive heart failure at day 90
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1876
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1

    Secondary: Composite of all-cause death, reinfarction, new congestive heart failure - long-term

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    End point title
    		 Composite of all-cause death, reinfarction, new congestive heart failure - long-term
    End point description
    End point type
    Secondary
    End point timeframe
    12 months
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    925
    921
    Units: patients
        patients with event
    85
    90
        patients without event
    840
    831
    Statistical analysis title
    		 Secondary: composite endpoint at 12 months
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1846
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.69
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.28

    Secondary: Creatine kinase - area under the curve

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    End point title
    		 Creatine kinase - area under the curve
    End point description
    The infarct size is assessed indirectly by the area under the curve of the creatine kinase and creatine kinase–MB release for measurements every 8 hours for 48 hours. For missing values, linear interpolation is used.
    End point type
    Secondary
    End point timeframe
    48 h
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    561
    545
    Units: microkat per L
        median (inter-quartile range (Q1-Q3))
    691 (361 to 1121)
    694 (354 to 1172)
    Statistical analysis title
    		 Secondary: creatine kinase AUC
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.87
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Creatine kinase MB - area under the curve

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    End point title
    		 Creatine kinase MB - area under the curve
    End point description
    The infarct size is assessed indirectly by the area under the curve of the creatine kinase and creatine kinase–MB release for measurements every 8 hours for 48 hours. For missing values, linear interpolation is used.
    End point type
    Secondary
    End point timeframe
    48 h
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    333
    318
    Units: microkat per L
        median (inter-quartile range (Q1-Q3))
    69 (38 to 105)
    71 (40 to 121)
    Statistical analysis title
    		 Secondary: Creatine kinase-MB AUC
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.19
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: ST segment resolution at 90 min

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    End point title
    		 ST segment resolution at 90 min
    End point description
    Improvement in tissue perfusion is assessed by serial electrocardiographic (ECG) measurements at 90 minutes (defined by the time point of the worst ECG before PCI) and at 24 hours after PCI. The ECG ST-segment resolution measurement is performed in the ECG core laboratory at the University of Leipzig–Heart Center by operators blinded to the patient's assigned treatment group. The sum of ST-segment elevation is measured 20 milliseconds after the end of the QRS complex in the initial and the follow-up ECGs. The ST-segment resolution is expressed as percentage.
    End point type
    Secondary
    End point timeframe
    90 min
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    851
    815
    Units: percent
        median (inter-quartile range (Q1-Q3))
    55 (25 to 77)
    53 (21 to 75)
    Statistical analysis title
    		 Secondary: ST-segment resolution at 90 min
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1666
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.36
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: ST segment resolution at 24 h

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    End point title
    		 ST segment resolution at 24 h
    End point description
    Improvement in tissue perfusion is assessed by serial electrocardiographic (ECG) measurements at 90 minutes (defined by the time point of the worst ECG before PCI) and at 24 hours after PCI. The ECG ST-segment resolution measurement is performed in the ECG core laboratory at the University of Leipzig–Heart Center by operators blinded to the patient's assigned treatment group. The sum of ST-segment elevation is measured 20 milliseconds after the end of the QRS complex in the initial and the follow-up ECGs. The ST-segment resolution is expressed as percentage.
    End point type
    Secondary
    End point timeframe
    24 h
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    721
    690
    Units: percent
        median (inter-quartile range (Q1-Q3))
    67 (40 to 82)
    66 (38 to 81)
    Statistical analysis title
    		 Secondary: ST-segment resolution at 24 h
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1411
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.59
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: TIMI flow post-PCI

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    End point title
    		 TIMI flow post-PCI
    End point description
    Epicardial perfusion is assessed by the TIMI flow post-PCI to show whether intracoronary abciximab administration leads to improved perfusion. The TIMI flow will be reported by the individual investigators
    End point type
    Secondary
    End point timeframe
    immediately after percutaneous coronary intervention (PCI)
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    996
    984
    Units: patients
        TIMI-flow 0
    17
    20
        TIMI-flow I
    15
    18
        TIMI-flow II
    81
    70
        TIMI-flow III
    883
    876
    Statistical analysis title
    		 Secondary: TIMI-flow post PCI
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1980
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.74
    Method
    		 Chi-squared
    Confidence interval

    Other pre-specified: GUSTO bleeding classification

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    End point title
    		 GUSTO bleeding classification
    End point description
    Safety endpoint: Bleeding until hospital discharge according to the GUSTO criteria: (a) severe or life-threatening: either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention, (b) moderate: bleeding that requires blood transfusion, but does not result in hemodynamic compromise, or (c) mild: bleeding that does not meet the criteria for either severe or moderate bleeding.
    End point type
    Other pre-specified
    End point timeframe
    up to discharge
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    986
    998
    Units: patients
        Life-threatening or severe bleeding
    26
    19
        Moderate bleeding
    27
    25
        Minor bleeding
    81
    85
        No bleeding
    852
    869
    Statistical analysis title
    		 Safety: GUSTO bleeding
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1984
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.72
    Method
    		 Chi-squared
    Confidence interval

    Other pre-specified: Hemodynamic compromise during abciximab bolus administration

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    End point title
    		 Hemodynamic compromise during abciximab bolus administration
    End point description
    Safety endpoint: Hemodynamic compromise, defined as drop >15 mm Hg during abciximab bolus infusion; life-threatening arrhythmia (ventricular fibrillation and tachycardia) during abciximab bolus administration is assessed for safety
    End point type
    Other pre-specified
    End point timeframe
    immediately after abciximab bolus administration
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    986
    998
    Units: patients
        patients with event
    1
    6
        patients without event
    985
    992
    Statistical analysis title
    		 Safety: hemodynamic compromise
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1984
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.06
    Method
    		 Chi-squared
    Confidence interval

    Post-hoc: Life-threatening arrhythmia during abciximab bolus administration

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    End point title
    		 Life-threatening arrhythmia during abciximab bolus administration
    End point description
    End point type
    Post-hoc
    End point timeframe
    immediately after abciximab bolus administration
    End point values
    		 Abciximab i.c. Abciximab i.v.
    Number of subjects analysed
    986
    998
    Units: patient
        patients with event
    17
    21
        patients without event
    969
    977
    Statistical analysis title
    		 Safety: Life-threatening arrhythmia
    Comparison groups
    Abciximab i.c. v Abciximab i.v.
    Number of subjects included in analysis
    1984
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.25
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    until discharge from hospital
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Abciximab i.c.
    Reporting group description
    		 Abciximab bolus intracoronary

    Reporting group title
    Abciximab i.v.
    Reporting group description
    		 Abciximab bolus intravenously

    Serious adverse events
    		 Abciximab i.c. Abciximab i.v.
    Total subjects affected by serious adverse events
         subjects affected / exposed
    46 / 986 (4.67%)
    45 / 998 (4.51%)
         number of deaths (all causes)
    42
    34
         number of deaths resulting from adverse events
    16
    18
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Artery dissection
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhage
         subjects affected / exposed
    7 / 986 (0.71%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    7 / 8
    1 / 1
         deaths causally related to treatment / all
    2 / 3
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemia
         subjects affected / exposed
    1 / 986 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Peripheral ischaemia
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    2 / 986 (0.20%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vessel perforation
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Implantable defibrillator insertion
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Resuscitation
         subjects affected / exposed
    1 / 986 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General disorders and administration site conditions
    Mucosal haemorrhage
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    3 / 986 (0.30%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Sudden cardiac death
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemothorax
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 986 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Ventricular septal defect
         subjects affected / exposed
    2 / 986 (0.20%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 986 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac perforation
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    5 / 986 (0.51%)
    7 / 998 (0.70%)
         occurrences causally related to treatment / all
    5 / 5
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Cardiogenic shock
         subjects affected / exposed
    2 / 986 (0.20%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dressler`s syndrome
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Papillary muscle rupture
    Additional description: Cardiac disorders
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 986 (0.20%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial haemorrhage
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricle rupture
         subjects affected / exposed
    1 / 986 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Ventricular fibrillation
         subjects affected / exposed
    4 / 986 (0.41%)
    7 / 998 (0.70%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Ventricular flutter
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    7 / 986 (0.71%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Nervous system disorders
    Brain injury
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    3 / 986 (0.30%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 986 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thrombocytopenia
         subjects affected / exposed
    1 / 986 (0.10%)
    4 / 998 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Acute abdomen
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 986 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 986 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Retroperitoneal haematoma
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    7 / 986 (0.71%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 6
    0 / 0
    Renal failure acute
         subjects affected / exposed
    1 / 986 (0.10%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Renal infarct
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Musculoskeletal and connective tissue disorders
    Compartment syndrome
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Abdominal sepsis
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    4 / 986 (0.41%)
    6 / 998 (0.60%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Puncture site infection
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 986 (0.30%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Septic encephalopathy
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 986 (0.00%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 986 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Lactic acidosis
         subjects affected / exposed
    1 / 986 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Abciximab i.c. Abciximab i.v.
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    157 / 986 (15.92%)
    171 / 998 (17.13%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    30 / 986 (3.04%)
    36 / 998 (3.61%)
         occurrences all number
    31
    36
    Haemorrhage
         subjects affected / exposed
    43 / 986 (4.36%)
    38 / 998 (3.81%)
         occurrences all number
    44
    38
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    26 / 986 (2.64%)
    33 / 998 (3.31%)
         occurrences all number
    28
    33
    Ventricular tachycardia
         subjects affected / exposed
    29 / 986 (2.94%)
    34 / 998 (3.41%)
         occurrences all number
    27
    33
    Surgical and medical procedures
    Percutaneous coronary intervention
         subjects affected / exposed
    31 / 986 (3.14%)
    31 / 998 (3.11%)
         occurrences all number
    39
    35

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Oct 2008
    Three new sites were added , and one site was be closed due to a shortage in qualified personal. The University of Leipzig / Herzzentrum implemented another scientific side project, which will only be conducted at the Herzzentrum. The trial medication which was distributed by Lilly Germany from Gießen (central German storage place) until the amendment was be distributed from the European storage place of Lilly in Belgium after the amendment. Mmanufacturer, contents and labeling remained unchanged. Due to a relative high morbidity of the patients participating in this clinical trial, potential SAEs directly related to the underlying disease do not have be reported following an expedited reporting of SAEs as long as there is no suspicion of it being a SUSAR.
    30 Mar 2009
    Two new sites were added, change of PI at one trial site. To obtain comparabel and reliable data concerning the data from the 90 day follow-up examination, the working-instructions were specified with respect to acceptable source data and verification of potential findings. The recruitment period wasextended to three years. Change ofthe trial acronym to avoid mixing-up between different trials with the same substance and in similar indications.
    11 May 2009
    Use of Prasugrel as alternative to Clopidogrel. Change in the definition of patients considered as drop-out. Addition of a new trialsite and closure of one trial site. Addition of investigators to already participating trial sites.
    19 Nov 2010
    Closure of five trial sites due to insufficient capacity for proper trial conduct . Addition of capture of the time point of signature on the short form of the informed consent. Disposal of surplus or expired medication at the trial centres themselves insteadof re-shipment to Lilly. Increase of the patient number participating in the scientific MRT substudy to 1000. Additional investigarors in already participating trial sites.

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22357109
    http://www.ncbi.nlm.nih.gov/pubmed/20362711
    http://www.ncbi.nlm.nih.gov/pubmed/23850911
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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