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    Clinical Trial Results:
    Revacept, a novel inhibitor of platelet adhesion in patients with stable coronary artery disease undergoing elective percutaneous coronary interventions: A phase II, multicentre, randomised, dose-finding, double-blind and placebo-controlled study.

    Summary
    EudraCT number
    		 2015-000686-32
    Trial protocol
    		 DE  
    Global end of trial date
    26 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 May 2021
    First version publication date
    05 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Revacept/CAD/02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03312855
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    German Heart Centre Munich
    Sponsor organisation address
    Lazarettstr. 36, Munich, Germany, 80636
    Public contact
    Prof. Dr. Adnan Kastrati, German Heart Centre Munich, 0049 8912184578, kastrati@dhm.mhn.de
    Scientific contact
    Prof. Dr. Adnan Kastrati, German Heart Centre Munich, 0049 8912184578, kastrati@dhm.mhn.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
    16 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective is to evaluate the efficacy and safety of treatment with 2 doses (80 and 160 mg) of Revacept versus placebo.
    Protection of trial subjects
    Not applicable.
    Background therapy
    		 Patients underwent perctaneous coronary intervention and periprocedural antithrombotic therapy composed of clopidogrel, ASA and heparin was administered based on local practice and current guidelines.
    Evidence for comparator
    		 No comparators used.
    Actual start date of recruitment
    14 Nov 2017
    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
    Germany: 334
    Worldwide total number of subjects
    334
    EEA total number of subjects
    334
    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)
    122
    From 65 to 84 years
    208
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 For inclusion the patients had to fulfil the following criteria: 1) Signed written informed consent 2) Target population a) Men and women aged >18 years b) Diagnosis: Clinically stable coronary artery disease c) Angiographic evidence of coronary artery disease d) Indication for PCI

    Pre-assignment period milestones
    Number of subjects started
    		 509 [1]
    Number of subjects completed
    		 334

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 3
    Reason: Number of subjects
    		 Not meeting inclusion criteria, exclusion criteria: 171
    Reason: Number of subjects
    		 Organisational reason: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre-assignment period is completed with the screening data. 509 patients were screened and 334 patients have been randomised.
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Revacept 160 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Revacept 160 mg
    Investigational medicinal product code
    Other name
    PR-15
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single administration over 20 minutes

    Arm title
    		 Revacept 80 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Revacept 80 mg
    Investigational medicinal product code
    Other name
    PR-15
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single administration over 20 minutes

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single administration over 20 minutes

    Number of subjects in period 1
    		Revacept 160 mg Revacept 80 mg Placebo
    Started
    120
    121
    93
    Completed
    117
    119
    92
    Not completed
    3
    2
    1
         Adverse event, serious fatal
    -
    1
    -
         Consent withdrawn by subject
    1
    -
    1
         Protocol deviation
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Revacept 160 mg
    Reporting group description
    		 -

    Reporting group title
    Revacept 80 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Revacept 160 mg Revacept 80 mg Placebo Total
    Number of subjects
    		 120 121 93 334
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 40 43 39 122
        From 65-84 years
    		 78 77 53 208
        85 years and over
    		 2 1 1 4
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 67.3 (61.5 to 75.5) 67.4 (60.4 to 75.1) 67.8 (60.8 to 74.8) -
    Gender categorical
    Units: Subjects
        Female
    		 38 24 19 81
        Male
    		 82 97 74 253
    Number of diseased vessels
    Units: Subjects
        one
    		 19 23 15 57
        two
    		 41 36 28 105
        three
    		 60 62 50 172
    Diabetes mellitus
    Units: Subjects
        Diabetes mellitus yes
    		 32 35 22 89
        Diabetes mellitus no
    		 88 86 71 245
    Smoker
    Units: Subjects
        Current smoker
    		 24 20 23 67
        Non-smoker
    		 96 101 70 267
    Arterial hypertension
    Units: Subjects
        Arterial hypertension yes
    		 106 103 87 296
        Arterial hypertension no
    		 14 18 6 38
    Hypercholesterolemia
    Units: Subjects
        Hypercholesterolemia yes
    		 110 108 80 298
        Hypercholesterolemia no
    		 10 13 13 36
    Myocardial infarction
    Units: Subjects
        Myocardial infarction yes
    		 21 27 26 74
        Myocardial infarction no
    		 99 94 67 260
    CABG
    Units: Subjects
        CABG yes
    		 10 11 6 27
        CABG no
    		 110 110 87 307
    Stroke
    Units: Subjects
        Stroke yes
    		 2 3 3 8
        Stroke no
    		 118 118 90 326
    Peripheral arterial occlusive disease
    Units: Subjects
        Peripheral arterial occlusive disease yes
    		 11 8 7 26
        Peripheral arterial occlusive disease no
    		 109 113 86 308
    COPD
    Units: Subjects
        COPD yes
    		 8 4 5 17
        COPD no
    		 112 117 88 317
    Kidney insufficiency
    Units: Subjects
        Kidney insufficiency yes
    		 14 12 5 31
        Kidney insufficiency no
    		 106 109 88 303
    Subject analysis sets

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The full-analysis set included all subjects who have been randomized in concordance with the intention-to-treat principle.

    Subject analysis sets values
    		 Intention-to-treat
    Number of subjects
    334
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    122
        From 65-84 years
    208
        85 years and over
    4
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    67.4 (60.8 to 75.0)
    Gender categorical
    Units: Subjects
        Female
    81
        Male
    253
    Number of diseased vessels
    Units: Subjects
        one
    57
        two
    105
        three
    172
    Diabetes mellitus
    Units: Subjects
        Diabetes mellitus yes
    89
        Diabetes mellitus no
    245
    Smoker
    Units: Subjects
        Current smoker
    67
        Non-smoker
    267
    Arterial hypertension
    Units: Subjects
        Arterial hypertension yes
    296
        Arterial hypertension no
    38
    Hypercholesterolemia
    Units: Subjects
        Hypercholesterolemia yes
    298
        Hypercholesterolemia no
    36
    Myocardial infarction
    Units: Subjects
        Myocardial infarction yes
    74
        Myocardial infarction no
    260
    CABG
    Units: Subjects
        CABG yes
    27
        CABG no
    307
    Stroke
    Units: Subjects
        Stroke yes
    8
        Stroke no
    326
    Peripheral arterial occlusive disease
    Units: Subjects
        Peripheral arterial occlusive disease yes
    26
        Peripheral arterial occlusive disease no
    308
    COPD
    Units: Subjects
        COPD yes
    17
        COPD no
    317
    Kidney insufficiency
    Units: Subjects
        Kidney insufficiency yes
    31
        Kidney insufficiency no
    303

    End points

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    End points reporting groups
    Reporting group title
    Revacept 160 mg
    Reporting group description
    		 -

    Reporting group title
    Revacept 80 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Intention-to-treat
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The full-analysis set included all subjects who have been randomized in concordance with the intention-to-treat principle.

    Primary: A composite end point of death or myocardial injury (defined as increase in cardiac biomarker – high-sensitivity cardiac troponin T of at least 5 times the upper limit of norm (ULN))

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    End point title
    		 A composite end point of death or myocardial injury (defined as increase in cardiac biomarker – high-sensitivity cardiac troponin T of at least 5 times the upper limit of norm (ULN))
    End point description
    End point type
    Primary
    End point timeframe
    within 48 hours from randomisation
    End point values
    		 Revacept 160 mg Revacept 80 mg Placebo Intention-to-treat
    Number of subjects analysed
    120
    121
    93
    334
    Units: Death or myocardial injury
    29
    30
    21
    80
    Statistical analysis title
    		 Primary end point (efficacy)
    Statistical analysis description
    Confirmatory hypothesis testing of the primary efficacy end point was performed in a sequential order. First, significance of the treatment effect across the three groups was assessed by a test for trend on a two-sided 5% significance level using a binary logistic regression model and by using the values 0, 1 and 2 to code the placebo group, the lower-dose Revacept group and the higher dose Revacept group as a continuous variable.
    Comparison groups
    Revacept 160 mg v Revacept 80 mg v Placebo
    Number of subjects included in analysis
    334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 test for trend
    Confidence interval

    Secondary: Safety end point (Bleeding BARC 2 or higher)

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    End point title
    		 Safety end point (Bleeding BARC 2 or higher)
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days after randomisation
    End point values
    		 Revacept 160 mg Revacept 80 mg Placebo
    Number of subjects analysed
    120
    119
    93
    Units: Bleedings BARC 2 or higher
    6
    7
    8
    Statistical analysis title
    		 Safety endpoint (Bleeding)
    Comparison groups
    Revacept 160 mg v Revacept 80 mg v Placebo
    Number of subjects included in analysis
    332
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Logistic
    Parameter type
    		 test for trend
    Confidence interval

    Secondary: Myocardial infarction

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    End point title
    		 Myocardial infarction
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days after randomisation
    End point values
    		 Revacept 160 mg Revacept 80 mg Placebo Intention-to-treat
    Number of subjects analysed
    120
    121
    93
    334
    Units: Number of patients
    3
    3
    2
    8
    No statistical analyses for this end point

    Secondary: Definite stent thrombosis

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    End point title
    		 Definite stent thrombosis
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days after randomisation
    End point values
    		 Revacept 160 mg Revacept 80 mg Placebo Intention-to-treat
    Number of subjects analysed
    120
    121
    93
    334
    Units: Number of patients
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Urgent coronary revascularisation

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    End point title
    		 Urgent coronary revascularisation
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days after randomisation
    End point values
    		 Revacept 160 mg Revacept 80 mg Placebo Intention-to-treat
    Number of subjects analysed
    120
    121
    93
    334
    Units: Number of patients
    0
    2
    0
    2
    No statistical analyses for this end point

    Secondary: Stroke

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    End point title
    		 Stroke
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days after randomisation
    End point values
    		 Revacept 160 mg Revacept 80 mg Placebo Intention-to-treat
    Number of subjects analysed
    120
    121
    93
    334
    Units: Number of patients
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: All-cause mortality

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    End point title
    		 All-cause mortality
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days after randomization
    End point values
    		 Revacept 160 mg Revacept 80 mg Placebo Intention-to-treat
    Number of subjects analysed
    120
    121
    93
    334
    Units: Number of patients
    0
    1
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Following the subject’s randomisation all adverse events were collected by the investigators. All adverse events were collected that occured until visit 3.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Revacept 160 mg
    Reporting group description
    		 -

    Reporting group title
    Revacept 80 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Revacept 160 mg Revacept 80 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 120 (10.00%)
    13 / 119 (10.92%)
    8 / 93 (8.60%)
         number of deaths (all causes)
    0
    1
    0
         number of deaths resulting from adverse events
    0
    1
    0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 120 (0.83%)
    2 / 119 (1.68%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Troponin T increased
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (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
    Injury, poisoning and procedural complications
    Vascular access site haemorrhage
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular access site haematoma
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (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
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (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
    Cardiac disorders
    Myocardial haemorrhage
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (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
    Acute myocardial infarction
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (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
    Ventricular fibrillation
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (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
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (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
    Seizure
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (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
    General disorders and administration site conditions
    Therapeutic response decreased
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (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
    Chest pain
         subjects affected / exposed
    1 / 120 (0.83%)
    2 / 119 (1.68%)
    4 / 93 (4.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis microscopic
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (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
    Gastroenteritis
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Revacept 160 mg Revacept 80 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 120 (55.00%)
    58 / 119 (48.74%)
    40 / 93 (43.01%)
    Vascular disorders
    Blood pressure fluctuation
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Haematoma
         subjects affected / exposed
    2 / 120 (1.67%)
    3 / 119 (2.52%)
    2 / 93 (2.15%)
         occurrences all number
    2
    3
    2
    Haemorrhage
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    1
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    2 / 93 (2.15%)
         occurrences all number
    1
    1
    2
    Hypotension
         subjects affected / exposed
    1 / 120 (0.83%)
    2 / 119 (1.68%)
    0 / 93 (0.00%)
         occurrences all number
    1
    2
    0
    Phlebitis
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Thrombophlebitis
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Surgical and medical procedures
    Cataract operation
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Catheter site phlebitis
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Chest pain
         subjects affected / exposed
    4 / 120 (3.33%)
    6 / 119 (5.04%)
    4 / 93 (4.30%)
         occurrences all number
    4
    6
    5
    Discomfort
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Drug intolerance
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    1
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 120 (1.67%)
    2 / 119 (1.68%)
    0 / 93 (0.00%)
         occurrences all number
    2
    2
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Therapeutic response decreased
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Testicular pain
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Menorrhagia
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 120 (0.00%)
    2 / 119 (1.68%)
    0 / 93 (0.00%)
         occurrences all number
    0
    2
    0
    Dyspnoea
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    1
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 120 (0.83%)
    3 / 119 (2.52%)
    0 / 93 (0.00%)
         occurrences all number
    1
    4
    0
    Pulmonary oedema
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Panic disorder
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Sleep disorder
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Restlessness
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 120 (0.00%)
    2 / 119 (1.68%)
    1 / 93 (1.08%)
         occurrences all number
    0
    2
    1
    Blood creatine phosphokinase MB increased
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    2 / 120 (1.67%)
    2 / 119 (1.68%)
    2 / 93 (2.15%)
         occurrences all number
    2
    2
    2
    Blood pressure diastolic increased
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 120 (1.67%)
    1 / 119 (0.84%)
    2 / 93 (2.15%)
         occurrences all number
    2
    1
    2
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Inflammatory marker increased
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Myocardial necrosis marker increased
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Troponin T increased
         subjects affected / exposed
    0 / 120 (0.00%)
    2 / 119 (1.68%)
    0 / 93 (0.00%)
         occurrences all number
    0
    2
    0
    Injury, poisoning and procedural complications
    Bone contusion
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac procedure complication
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Heat stroke
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Muscle rupture
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Product administration error (not IMP)
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Scratch
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular access site haematoma
         subjects affected / exposed
    15 / 120 (12.50%)
    8 / 119 (6.72%)
    7 / 93 (7.53%)
         occurrences all number
    15
    8
    7
    Vascular access site haemorrhage
         subjects affected / exposed
    0 / 120 (0.00%)
    2 / 119 (1.68%)
    1 / 93 (1.08%)
         occurrences all number
    0
    2
    1
    Vascular access site occlusion
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    1
    0
    1
    Vascular access site pain
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    2
    0
    1
    Vascular access site pseudoaneurysm
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    1
    Angina pectoris
         subjects affected / exposed
    2 / 120 (1.67%)
    2 / 119 (1.68%)
    0 / 93 (0.00%)
         occurrences all number
    2
    2
    0
    Bradycardia
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Bundle branch block left
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Coronary artery dissection
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    2 / 93 (2.15%)
         occurrences all number
    0
    1
    2
    Palpitations
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    2
    Tachycardia
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Cerebral artery occlusion
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Craniocervical syndrome
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    1
    Dizziness postural
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    1
    Headache
         subjects affected / exposed
    1 / 120 (0.83%)
    2 / 119 (1.68%)
    1 / 93 (1.08%)
         occurrences all number
    1
    2
    1
    Insomnia
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Neurological symptom
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    2 / 120 (1.67%)
    2 / 119 (1.68%)
    0 / 93 (0.00%)
         occurrences all number
    2
    2
    0
    Presyncope
         subjects affected / exposed
    5 / 120 (4.17%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    5
    0
    1
    Sleep deficit
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 119 (0.00%)
    2 / 93 (2.15%)
         occurrences all number
    2
    0
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    6 / 120 (5.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    6
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 120 (1.67%)
    2 / 119 (1.68%)
    0 / 93 (0.00%)
         occurrences all number
    4
    3
    0
    Dyspepsia
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Erosive duodenitis
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Gastritis erosive
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 120 (0.83%)
    3 / 119 (2.52%)
    3 / 93 (3.23%)
         occurrences all number
    1
    3
    3
    Paraesthesia oral
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Cold sweat
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    1
    1
    0
    Night sweats
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Arthritis
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Back pain
         subjects affected / exposed
    1 / 120 (0.83%)
    3 / 119 (2.52%)
    3 / 93 (3.23%)
         occurrences all number
    1
    3
    3
    Joint effusion
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Limb discomfort
         subjects affected / exposed
    0 / 120 (0.00%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    0
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    2 / 93 (2.15%)
         occurrences all number
    1
    1
    2
    Musculoskeletal pain
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    1 / 93 (1.08%)
         occurrences all number
    1
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    1 / 93 (1.08%)
         occurrences all number
    0
    1
    1
    Spinal pain
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    1
    0
    0
    Tenosynovitis
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    11 / 120 (9.17%)
    6 / 119 (5.04%)
    4 / 93 (4.30%)
         occurrences all number
    11
    6
    4
    Sinusitis
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Viral infection
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 119 (0.84%)
    0 / 93 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 119 (0.84%)
    1 / 93 (1.08%)
         occurrences all number
    1
    1
    1
    Hypokalaemia
         subjects affected / exposed
    2 / 120 (1.67%)
    1 / 119 (0.84%)
    2 / 93 (2.15%)
         occurrences all number
    2
    1
    2
    Hyponatraemia
         subjects affected / exposed
    2 / 120 (1.67%)
    0 / 119 (0.00%)
    0 / 93 (0.00%)
         occurrences all number
    2
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Dec 2016
    Substantial amendment: Protocol Version 4.0 (29 Nov 2016) (not approved) - Change of the sponsor representative in Prof. Dr. A. Kastrati - Members of Steering Committee and involved parties added - Discrepancies in description of primary and secondary end points between synopsis and main protocol corrected - Revision of secondary end points - Number of study participants changed to 332 instead of 330 - Exclusion criteria described more precisely - Study duration was added - Randomisation process was amended, unblinding process added - Details of conduct of the study specified - Definitions corrected and missing definitions added in adverse event section - Data management processes described more precisely - Sample size calculation was amended and number of patients increased fom 330 to 332 - Statistical analysis amended (adapted to compare the 3 treatment groups) - Section of Data Safety Monitoring Board and Event Adjudication Committee amended - No core laboratory involved - Important definitions added for bleeding, myocardial infarction, revascularisation, acute coronary syndrome, angiographic success of PCI, diabetes mellitus, smoking status, hypercholesterolemia, multivessel disease, TIMI grade flow
    21 Mar 2017
    Substantial amendment: Protocol Version 5.0 (20 Mar 2017) - Sample size estimation and statistical analysis amended due to BfArM’s request
    11 May 2017
    Substantial amendment: Protocol Version 6.0 (10 May 2017) - Peri-procedural treatment was changed, the dose of clopidogrel is not specified anymore, the administration is based on local practice and current guidelines - The primary and secondary end points were related to the time of randomisation - Statistical methods: Clarification, that an overall evaluation of both efficacy and safety findings will be performed - The rational for a predefined dose of clopidogrel as peri-procedural therapy was removed - Randomisation is performed with the use of an computerised system embedded in the eCRF, revision of randomisation is not allowed, section removed - In vitro bleeding test was removed - Clinical chemistry and haematoloy parameters were described more precisely - Body temperature as safety parameter was added - AE/SAE definitions adapted to CT-3 guideline - Analysis of safety end points according to modified intention to treat principle - References amended - Definitions amended (myocadial infarction, revascularisation, stable angina pectoris, arterial hypertension, complex lesions)
    13 Apr 2018
    Substantial amendment: Protocol Version 7.0 (10 Apr 2018) - Primary end point: only high-sensitive troponin T - Secondary end point: Peak high-sensitivity troponin T level within 48 hours instead of 30 days - Exclusion criteria added: o Patients with elevated high-sensitivity cardiac troponin T levels at screening o Patients receiving antithrombotic therapy with Prasugrel or Ticagrelor within 7 days prior to randomisation - It was explained more precisely that data obtained as part of the normal subject care can be used for visit 1/screening and visit 2. The screening data are considered valid only if collected within 2 days prior to randomisation. - Definition of stroke corrected
    11 Jun 2019
    Substantial amendment: Protocol Version 8.0 (11 Jun 2019) - Trial duration amended - Additional laboratory assessment: platelet related inflammatory mediators and platelet released microRNA

    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/33787834
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