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    Clinical Trial Results:
    A Randomised Controlled Trial Investigating the Pharmacodynamic Effect of Ticagrelor Monotherapy on Platelet Reactivity in Patients with Coronary Artery Disease: The TEMPLATE Study

    Summary
    EudraCT number
    		 2013-002734-20
    Trial protocol
    		 GB  
    Global end of trial date
    21 Oct 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Feb 2021
    First version publication date
    18 Feb 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CS/2014/4525
    Additional study identifiers
    ISRCTN number
    		 ISRCTN84335288
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Research & Innovation, University Hospitals Bristol NHS Foundation Trust
    Sponsor organisation address
    Education & Research Centre, Level 3, Upper Maudlin Street, Bristol, United Kingdom, BS2 8AE
    Public contact
    Andrew Mumford, University of Bristol, 44 0117 342 3152, andrew.mumford@bristol.ac.uk
    Scientific contact
    Andrew Mumford, University of Bristol, 44 0117 342 3152, andrew.mumford@bristol.ac.uk
    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
    22 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The overall study aim is to determine whether aspirin is required to achieve full platelet inhibition in patients with coronary artery disease who are also receiving ticagrelor. We will investigate this by comparing the pharmacodynamic effects of aspirin + ticagrelor (ASP + TIC) and ticagrelor alone (TIC) on platelets from patients allocated at random to the intervention.
    Protection of trial subjects
    Trial participants were closely followed up to identify any adverse reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 110
    Worldwide total number of subjects
    110
    EEA total number of subjects
    0
    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)
    45
    From 65 to 84 years
    60
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 110
    Number of subjects completed

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ASP + TIC
    Arm description
    		 Loading dose of 180mg ticagrelor followed by aspirin 75mg/day AND ticagrelor 90 mg b.d. for 4 weeks unless the patient is already on ASP+TIC
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    aspirin 75mg/day for 4 weeks unless the patient is already on ASP+TIC

    Investigational medicinal product name
    Ticagrelor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Loading dose of 180mg ticagrelor followed by ticagrelor 90 mg b.d. for 4 weeks unless the patient is already on ASP+TIC

    Arm title
    		 TIC alone
    Arm description
    		 Loading dose of 180mg ticagrelor followed by ticagrelor 90 mg b.d. for 4 weeks unless the patient is already on ASP+TIC
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ticagrelor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Loading dose of 180mg ticagrelor followed by ticagrelor 90 mg b.d. for 4 weeks unless the patient is already on ASP+TIC

    Number of subjects in period 1
    		ASP + TIC TIC alone
    Started
    55
    55
    Completed
    49
    53
    Not completed
    6
    2
         Not possible to schedule visit 2
    1
    -
         Ineligible
    -
    1
         Patient unhappy with side effects
    1
    -
         Can no longer attend visit schedule
    -
    1
         Patient died
    1
    -
         GP
    1
    -
         Patient no longer wanted to take part
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ASP + TIC
    Reporting group description
    		 Loading dose of 180mg ticagrelor followed by aspirin 75mg/day AND ticagrelor 90 mg b.d. for 4 weeks unless the patient is already on ASP+TIC

    Reporting group title
    TIC alone
    Reporting group description
    		 Loading dose of 180mg ticagrelor followed by ticagrelor 90 mg b.d. for 4 weeks unless the patient is already on ASP+TIC

    Reporting group values
    		 ASP + TIC TIC alone Total
    Number of subjects
    		 55 55 110
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.3 ± 10.3 66.1 ± 11.8 -
    Gender categorical
    Units: Subjects
        Female
    		 11 11 22
        Male
    		 44 44 88
    Smoking history
    Units: Subjects
        Yes
    		 6 7 13
        Ex-smoker >1 month
    		 29 27 56
        Never
    		 20 21 41
    Family history of heart disease
    Units: Subjects
        Yes
    		 29 21 50
        No
    		 26 34 60
    Hypertension requiring treatment
    Units: Subjects
        Yes
    		 26 31 57
        No
    		 29 24 53
    Hypercholesterolaemia
    Units: Subjects
        Yes
    		 30 31 61
        No
    		 25 24 49
    Diabetes
    Units: Subjects
        Insulin
    		 3 4 7
        Oral
    		 5 4 9
        Diet
    		 1 0 1
        None
    		 46 47 93
    Congestive heart failure
    Units: Subjects
        Yes
    		 4 1 5
        No
    		 51 54 105
    CVA/TIA
    Units: Subjects
        Yes
    		 3 3 6
        No
    		 52 52 104
    Chronic pulmonary disease
    Units: Subjects
        Yes
    		 0 2 2
        No
    		 55 53 108
    Asthma
    Units: Subjects
        Yes
    		 6 5 11
        No
    		 49 50 99
    Peripheral vascular disease
    Units: Subjects
        Yes
    		 2 1 3
        No
    		 53 54 107
    Hypothyroidism
    Units: Subjects
        Yes
    		 3 6 9
        No
    		 52 49 101
    Previous PCI
    Units: Subjects
        Yes
    		 12 15 27
        No
    		 43 40 83
    Previous cardiac surgery
    Units: Subjects
        Yes
    		 5 4 9
        No
    		 50 51 101
    Previous MI
    Units: Subjects
        Yes
    		 27 30 57
        No
    		 28 25 53
    Heart rhythm
    Units: Subjects
        Sinus
    		 55 53 108
        Block
    		 0 1 1
        Missing
    		 0 1 1
    Other medical history
    Units: Subjects
        Yes
    		 42 40 82
        No
    		 13 15 28
    LV function
    Units: Subjects
        Good (>50%)
    		 36 38 74
        Moderate (30-50%)
    		 17 14 31
        Poor (<30%)
    		 0 1 1
        Missing
    		 2 2 4
    >50% disease in left main stem
    Units: Subjects
        Yes
    		 4 3 7
        No
    		 51 52 103
    Coronary disease, number of vessels
    Units: Subjects
        Single
    		 26 28 54
        Double
    		 21 14 35
        Triple
    		 8 13 21
    Pacemaker
    Units: Subjects
        Yes
    		 0 2 2
        No
    		 55 53 108
    Aspirin
    Units: Subjects
        Yes
    		 55 55 110
        No
    		 0 0 0
    Clopidogrel
    Units: Subjects
        Yes
    		 19 20 39
        No
    		 36 35 71
    Ticagrelor
    Units: Subjects
        Yes
    		 23 25 48
        No
    		 32 30 62
    Prasugrel
    Units: Subjects
        Yes
    		 13 10 23
        No
    		 42 45 87
    Warfarin
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 55 55 110
    Heparin
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 55 55 110
    Clexane
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 55 55 110
    Fondaparinux
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 55 55 110
    Beta blockers
    Units: Subjects
        Yes
    		 43 42 85
        No
    		 12 13 25
    Calcium antagonists
    Units: Subjects
        Yes
    		 11 9 20
        No
    		 44 46 90
    ACE inhibitors
    Units: Subjects
        Yes
    		 35 37 72
        No
    		 20 18 38
    Angiotensin II blockers
    Units: Subjects
        Yes
    		 6 12 18
        No
    		 49 43 92
    Statins
    Units: Subjects
        Yes
    		 54 51 105
        No
    		 1 4 5
    Other lipid lowering agent
    Units: Subjects
        Yes
    		 1 4 5
        No
    		 54 51 105
    Oral nitrates
    Units: Subjects
        Yes
    		 18 13 31
        No
    		 37 42 79
    Nicorandil
    Units: Subjects
        Yes
    		 2 1 3
        No
    		 53 54 107
    Diuretics
    Units: Subjects
        Yes
    		 4 9 13
        No
    		 51 46 97
    Oral anti-diabetics
    Units: Subjects
        Yes
    		 3 4 7
        No
    		 52 51 103
    Insulin
    Units: Subjects
        Yes
    		 7 6 13
        No
    		 48 49 97
    Anti arrhythmic
    Units: Subjects
        Yes
    		 26 24 50
        No
    		 29 31 60
    PPIs
    Units: Subjects
        Yes
    		 0 0 0
        No
    		 55 55 110
    Other medications
    Units: Subjects
        Yes
    		 29 40 69
        No
    		 26 15 41
    Heart rate
    Units: rpm
        arithmetic mean (standard deviation)
    		 62.7 ± 10.1 62.1 ± 10.9 -
    Systolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 135.8 ± 14.6 140.8 ± 20.0 -
    Diastolic blood pressure
    Units: mmHg
        arithmetic mean (standard deviation)
    		 76.9 ± 10.9 78.5 ± 10.9 -
    BMI
    Units: unitless
        arithmetic mean (standard deviation)
    		 27.6 ± 3.8 27.0 ± 4.9 -

    End points

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    End points reporting groups
    Reporting group title
    ASP + TIC
    Reporting group description
    		 Loading dose of 180mg ticagrelor followed by aspirin 75mg/day AND ticagrelor 90 mg b.d. for 4 weeks unless the patient is already on ASP+TIC

    Reporting group title
    TIC alone
    Reporting group description
    		 Loading dose of 180mg ticagrelor followed by ticagrelor 90 mg b.d. for 4 weeks unless the patient is already on ASP+TIC

    Primary: MA of the LTA response of PRP to TRAP-6

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    End point title
    		 MA of the LTA response of PRP to TRAP-6
    End point description
    The primary outcome is defined as the maximum amplitude of the light transmission aggregation response of platelet rich plasma (PRP) to TRAP-6 expressed as a % of the absolute difference in light transmission between PRP and platelet poor plasma. This assay measures the ability of platelets to aggregate when exposed to the aggregation promoting agent TRAP-6.
    End point type
    Primary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2. primary analysis is comparing the treatment groups at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    47
    52
    Units: 10uM
        arithmetic mean (standard deviation)
    80.9 ± 13.6
    85.5 ± 13.4
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    ASP + TIC v TIC alone
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.103
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    4.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.87
         upper limit
    		 9.46

    Secondary: MA of the LTA response of PRP to TRAP-6 5uM

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    End point title
    		 MA of the LTA response of PRP to TRAP-6 5uM
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2. primary analysis is comparing the treatment groups at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    47
    52
    Units: uM
        arithmetic mean (standard deviation)
    70.1 ± 20.3
    77.8 ± 20.2
    No statistical analyses for this end point

    Secondary: MA of the LTA response of PRP to CRP 1ug/mL

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    End point title
    		 MA of the LTA response of PRP to CRP 1ug/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2. primary analysis is comparing the treatment groups at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    47
    52
    Units: mg/mL
        arithmetic mean (standard deviation)
    85.6 ± 9.9
    92.5 ± 12.3
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    ASP + TIC v TIC alone
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.04
         upper limit
    		 10.9

    Secondary: MA of the LTA response of PRP to CRP 0.5ug/mL

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    End point title
    		 MA of the LTA response of PRP to CRP 0.5ug/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2. primary analysis is comparing the treatment groups at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    47
    51
    Units: ug/mL
        arithmetic mean (standard deviation)
    72.8 ± 15.6
    87.8 ± 13.7
    No statistical analyses for this end point

    Secondary: MA of the LTA response of PRP to U46619 5uM

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    End point title
    		 MA of the LTA response of PRP to U46619 5uM
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2. primary analysis is comparing the treatment groups at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    47
    52
    Units: uM
        arithmetic mean (standard deviation)
    74.0 ± 12.4
    73.2 ± 13.8
    No statistical analyses for this end point

    Secondary: MA of the LTA response of PRP to U46619 2.5uM

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    End point title
    		 MA of the LTA response of PRP to U46619 2.5uM
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2. primary analysis is comparing the treatment groups at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    47
    52
    Units: uM
        arithmetic mean (standard deviation)
    48.3 ± 16.5
    48.6 ± 20.6
    No statistical analyses for this end point

    Secondary: MA of the LTA response of PRP to ADP 10uM

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    End point title
    		 MA of the LTA response of PRP to ADP 10uM
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2. primary analysis is comparing the treatment groups at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    46
    52
    Units: uM
        arithmetic mean (standard deviation)
    35.6 ± 11.6
    37.6 ± 12.5
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    ASP + TIC v TIC alone
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.709
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.89
         upper limit
    		 7.19

    Secondary: MA of the LTA response of PRP to AA 1mM

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    End point title
    		 MA of the LTA response of PRP to AA 1mM
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2. primary analysis is comparing the treatment groups at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    47
    52
    Units: mM
        median (inter-quartile range (Q1-Q3))
    5 (3 to 8)
    75 (59 to 83)
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    ASP + TIC v TIC alone
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Log mean difference
    Point estimate
    11.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.55
         upper limit
    		 15.95

    Secondary: Flow cytometry of PAC-1 after activation with TRAP-6 10uM

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    End point title
    		 Flow cytometry of PAC-1 after activation with TRAP-6 10uM
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2, before and after activation and the change. Primary analysis is comparing the treatment groups change at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    48
    53
    Units: uM
        median (inter-quartile range (Q1-Q3))
    1285.5 (1064 to 2565)
    1206 (980 to 1745)
    No statistical analyses for this end point

    Secondary: Flow cytometry of PAC-1 after activation with CRP 1ug/mL

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    End point title
    		 Flow cytometry of PAC-1 after activation with CRP 1ug/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2, before and after activation and the change. Primary analysis is comparing the treatment groups change at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    48
    50
    Units: ug/mL
        median (inter-quartile range (Q1-Q3))
    3127.5 (2079 to 4401.5)
    3055.5 (2244 to 3752)
    No statistical analyses for this end point

    Secondary: Flow cytometry of CD62P after activation with TRAP-6 10uM

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    End point title
    		 Flow cytometry of CD62P after activation with TRAP-6 10uM
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2, before and after activation and the change. Primary analysis is comparing the treatment groups change at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    48
    52
    Units: uM
        median (inter-quartile range (Q1-Q3))
    3011.5 (2569.5 to 5811.5)
    2893 (1931 to 4957)
    No statistical analyses for this end point

    Secondary: Flow cytometry of CD62P after activation with CRP 1ug/mL

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    End point title
    		 Flow cytometry of CD62P after activation with CRP 1ug/mL
    End point description
    End point type
    Secondary
    End point timeframe
    Data collected at baseline, visit 1 and visit 2, before and after activation and the change. Primary analysis is comparing the treatment groups change at visit 2.
    End point values
    		 ASP + TIC TIC alone
    Number of subjects analysed
    48
    49
    Units: ug/mL
        median (inter-quartile range (Q1-Q3))
    3405 (1985 to 7232.5)
    3350 (2468 to 5161)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Data on adverse events were collected from consent for the duration of the participant’s participation in the trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    ASP + TIC
    Reporting group description
    		 Loading dose of 180mg ticagrelor followed by aspirin 75mg/day AND ticagrelor 90 mg b.d. for 4 weeks unless the patient is already on ASP+TIC

    Reporting group title
    TIC alone
    Reporting group description
    		 Loading dose of 180mg ticagrelor followed by ticagrelor 90 mg b.d. for 4 weeks unless the patient is already on ASP+TIC

    Serious adverse events
    		 ASP + TIC TIC alone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 55 (3.64%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Coronary revascularisation
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin reaction
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ASP + TIC TIC alone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 55 (69.09%)
    45 / 55 (81.82%)
    Vascular disorders
    Epistaxis
         subjects affected / exposed
    4 / 55 (7.27%)
    0 / 55 (0.00%)
         occurrences all number
    4
    0
    Haemorrhage subcutaneous
         subjects affected / exposed
    3 / 55 (5.45%)
    2 / 55 (3.64%)
         occurrences all number
    3
    2
    Haematoma
         subjects affected / exposed
    20 / 55 (36.36%)
    12 / 55 (21.82%)
         occurrences all number
    20
    12
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Wound haemorrhage
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 55 (1.82%)
         occurrences all number
    2
    1
    Traumatic haemorrhage
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 55 (1.82%)
         occurrences all number
    2
    1
    Haemorrhage
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 55 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Confusion postoperative
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 55 (1.82%)
         occurrences all number
    2
    1
    Headache
         subjects affected / exposed
    3 / 55 (5.45%)
    4 / 55 (7.27%)
         occurrences all number
    3
    4
    Paraesthesia
         subjects affected / exposed
    1 / 55 (1.82%)
    4 / 55 (7.27%)
         occurrences all number
    1
    4
    Vertigo
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Other
    Additional description: Other adverse events
         subjects affected / exposed
    17 / 55 (30.91%)
    24 / 55 (43.64%)
         occurrences all number
    25
    32
    Eye disorders
    Eye haemorrhage
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Mouth haemorrhage
         subjects affected / exposed
    1 / 55 (1.82%)
    3 / 55 (5.45%)
         occurrences all number
    1
    3
    Abdominal pain
         subjects affected / exposed
    3 / 55 (5.45%)
    3 / 55 (5.45%)
         occurrences all number
    3
    3
    Nausea
         subjects affected / exposed
    5 / 55 (9.09%)
    6 / 55 (10.91%)
         occurrences all number
    6
    9
    Vomiting
         subjects affected / exposed
    3 / 55 (5.45%)
    4 / 55 (7.27%)
         occurrences all number
    3
    6
    Diarrhoea
         subjects affected / exposed
    4 / 55 (7.27%)
    14 / 55 (25.45%)
         occurrences all number
    6
    14
    Constipation
         subjects affected / exposed
    0 / 55 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2
    Dyspepsia
         subjects affected / exposed
    1 / 55 (1.82%)
    7 / 55 (12.73%)
         occurrences all number
    1
    8
    Hepatobiliary disorders
    Liver function test abnormal
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    Dyspnoea
         subjects affected / exposed
    15 / 55 (27.27%)
    18 / 55 (32.73%)
         occurrences all number
    15
    18
    Skin and subcutaneous tissue disorders
    Skin reaction
         subjects affected / exposed
    3 / 55 (5.45%)
    8 / 55 (14.55%)
         occurrences all number
    4
    10
    Renal and urinary disorders
    Fluid retention
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 55 (3.64%)
         occurrences all number
    2
    2
    Blood creatinine increased
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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