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    Clinical Trial Results:
    Bivalirudin versus Heparin in NST and ST-Evaluation myocardial infarction in patients on modern antiplatelet therapy in SWEDEHEART (the VALIDATE-SWEDEHEART-trial)

    Summary
    EudraCT number
    		 2012-005260-10
    Trial protocol
    		 SE  
    Global end of trial date
    10 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Feb 2019
    First version publication date
    13 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    U-2013-028
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Uppsala Clinical Research Center (UCR)
    Sponsor organisation address
    Dag Hammarskjölds väg 38, Uppsala, Sweden, 751 85
    Public contact
    Jonas Oldgren, Uppsala Clinical Research Center, +46 18 611 2765, jonas.oldgren@ucr.uu.se
    Scientific contact
    David Erlinge, Skåne University Hospital, Department of Cardiology, +46 46 172597, david.erlinge@med.lu.se
    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
    10 Mar 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare all-cause death, MI, and bleeding events in patients with STEMI and NSTEMI at 180 days, treated with PCI and either Bivalirudin infusion or Heparin i.v. according to local protocol.
    Protection of trial subjects
    An independent Data Safety Monitoring Board (DSMB) (sometimes referred to as a Data Safety Monitoring Committee (DSMC)) is responsible for safeguarding the interest of trial participants, assessing the safety of the interventions during the trial, and for monitoring the overall conduct of the clinical trial. This committee is also responsible for making recommendations to the study leadership to continue or terminate the trial with regard to safety considerations based on reports provided by an unblinded statistician.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jun 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 10 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 6006
    Worldwide total number of subjects
    6006
    EEA total number of subjects
    6006
    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)
    2327
    From 65 to 84 years
    3362
    85 years and over
    317

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients were recruited among those referred to the centers for PCI because of STEMI or NSTEMI. NSTEMI patients provided written consent before angiography, while STEMI patients first gave a witnessed consent before diagnostic coronary angiography in the catheterization lab followed by signing informed consent within 48h if they wished to continue.

    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
    		 Heparin-STEMI
    Arm description
    		 Treatment with heparin i.v. alone (according to local practice) in patients with ST-elevation myocardial infarction (STEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Heparin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intraarterial use, Intravenous bolus use
    Dosage and administration details
    The control group received treatment with unfractionated heparin. Heparin was administered as an intravenous or intra-arterial bolus according to local practice. A dose of 70-100U/kg was recommended.

    Arm title
    		 Bivalirudin-STEMI
    Arm description
    		 Treatment with Bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg per kilogram per hour in patients with ST-elevation myocardial infarction (STEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bivalirudin
    Investigational medicinal product code
    Other name
    Angiox
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    Bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg per kilogram per hour (optional to add up to 3000U heparin in lab or up to 5000U given pre-hospital).

    Arm title
    		 Heparin-NSTEMI
    Arm description
    		 Treatment with heparin i.v. alone (according to local practice) in patients with non-ST-elevation myocardial infarction (NSTEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Heparin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intraarterial use, Intravenous bolus use
    Dosage and administration details
    The control group received treatment with unfractionated heparin. Heparin was administered as an intravenous or intra-arterial bolus according to local practice. A dose of 70-100U/kg was recommended.

    Arm title
    		 Bivalirudin-NSTEMI
    Arm description
    		 Treatment with Bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg per kilogram per hour in patients with non-ST-elevation myocardial infarction (NSTEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bivalirudin
    Investigational medicinal product code
    Other name
    Angiox
    Pharmaceutical forms
    Infusion, Injection
    Routes of administration
    Intravenous bolus use , Intravenous use
    Dosage and administration details
    Bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg per kilogram per hour (optional to add up to 3000U heparin in lab or up to 5000U given pre-hospital).

    Number of subjects in period 1
    		Heparin-STEMI Bivalirudin-STEMI Heparin-NSTEMI Bivalirudin-NSTEMI
    Started
    1504
    1501
    1498
    1503
    Completed
    1489
    1482
    1479
    1488
    Not completed
    15
    19
    19
    15
         Consent withdrawn by subject
    11
    12
    14
    12
         Lost to follow-up
    4
    7
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Heparin-STEMI
    Reporting group description
    		 Treatment with heparin i.v. alone (according to local practice) in patients with ST-elevation myocardial infarction (STEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.

    Reporting group title
    Bivalirudin-STEMI
    Reporting group description
    		 Treatment with Bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg per kilogram per hour in patients with ST-elevation myocardial infarction (STEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.

    Reporting group title
    Heparin-NSTEMI
    Reporting group description
    		 Treatment with heparin i.v. alone (according to local practice) in patients with non-ST-elevation myocardial infarction (NSTEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.

    Reporting group title
    Bivalirudin-NSTEMI
    Reporting group description
    		 Treatment with Bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg per kilogram per hour in patients with non-ST-elevation myocardial infarction (NSTEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.

    Reporting group values
    		 Heparin-STEMI Bivalirudin-STEMI Heparin-NSTEMI Bivalirudin-NSTEMI Total
    Number of subjects
    		 1504 1501 1498 1503 6006
    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)
    		 67.0 ± 10.9 66.6 ± 11.4 67.6 ± 11.0 67.6 ± 10.7 -
    Gender categorical
    Units: Subjects
        Female
    		 417 407 404 364 1592
        Male
    		 1086 1090 1091 1139 4406
        No data
    		 1 4 3 0 8
    Smoking
    Units: Subjects
        Never
    		 604 589 581 593 2367
        Ex smoker >1 month
    		 428 446 592 581 2047
        Smoker
    		 419 417 291 299 1426
        Unknown
    		 52 45 31 30 158
        No data
    		 1 4 3 0 8
    BMI (kg/m2)
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.2 ± 5.3 27.3 ± 5.3 27.7 ± 4.4 27.7 ± 7.2 -
    Weight (kg)
    Units: kg
        arithmetic mean (standard deviation)
    		 82.2 ± 15.5 82.4 ± 15.7 83.6 ± 15.8 83.7 ± 16.3 -
    Subject analysis sets

    Subject analysis set title
    Heparin-STEMI (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis set title
    Bivalirudin-STEMI (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis set title
    Heparin-NSTEMI (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis set title
    Bivalirudin-NSTEMI (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis set title
    Heparin (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis set title
    Bivalirudin (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis sets values
    		 Heparin-STEMI (ITT) Bivalirudin-STEMI (ITT) Heparin-NSTEMI (ITT) Bivalirudin-NSTEMI (ITT) Heparin (ITT) Bivalirudin (ITT)
    Number of subjects
    1504
    1501
    1498
    1503
    3002
    3004
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    67.0 ± 10.9
    66.6 ± 11.4
    67.6 ± 11.0
    67.6 ± 10.7
    67.3 ± 11.0
    67.1 ± 11.1
    Gender categorical
    Units: Subjects
        Female
    417
    407
    404
    364
    821
    771
        Male
    1086
    1090
    1091
    1139
    2177
    2229
        No data
    1
    4
    3
    0
    4
    4
    Smoking
    Units: Subjects
        Never
    604
    589
    581
    593
    1185
    1182
        Ex smoker >1 month
    428
    446
    592
    581
    1020
    1027
        Smoker
    419
    417
    291
    299
    710
    716
        Unknown
    52
    45
    31
    30
    83
    75
        No data
    1
    4
    3
    0
    4
    4
    BMI (kg/m2)
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.2 ± 5.3
    27.3 ± 5.3
    27.7 ± 4.4
    27.7 ± 7.2
    27.5 ± 4.8
    27.5 ± 6.4
    Weight (kg)
    Units: kg
        arithmetic mean (standard deviation)
    82.2 ± 15.5
    82.4 ± 15.7
    83.6 ± 15.8
    83.7 ± 16.3
    82.9 ± 15.7
    83.1 ± 16.0

    End points

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    End points reporting groups
    Reporting group title
    Heparin-STEMI
    Reporting group description
    		 Treatment with heparin i.v. alone (according to local practice) in patients with ST-elevation myocardial infarction (STEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.

    Reporting group title
    Bivalirudin-STEMI
    Reporting group description
    		 Treatment with Bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg per kilogram per hour in patients with ST-elevation myocardial infarction (STEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.

    Reporting group title
    Heparin-NSTEMI
    Reporting group description
    		 Treatment with heparin i.v. alone (according to local practice) in patients with non-ST-elevation myocardial infarction (NSTEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.

    Reporting group title
    Bivalirudin-NSTEMI
    Reporting group description
    		 Treatment with Bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg per kilogram per hour in patients with non-ST-elevation myocardial infarction (NSTEMI) treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.

    Subject analysis set title
    Heparin-STEMI (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis set title
    Bivalirudin-STEMI (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis set title
    Heparin-NSTEMI (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis set title
    Bivalirudin-NSTEMI (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis set title
    Heparin (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Subject analysis set title
    Bivalirudin (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population is defined as any patient with data who was intentionally randomized.

    Primary: Difference in all-cause death, myocardial infarction, or major bleeding events in patients with STEMI and NSTEMI at 180 days, treated with PCI and either Bivalirudin infusion or Heparin i.v. according to local protocol.

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    End point title
    		 Difference in all-cause death, myocardial infarction, or major bleeding events in patients with STEMI and NSTEMI at 180 days, treated with PCI and either Bivalirudin infusion or Heparin i.v. according to local protocol.
    End point description
    Events were followed up using SWEDEHEART and other national registries and telephone contact at 7 and 180 days from randomization. Patients without events were censored on day 180 for derived 180 day completers, and recorded day of discontinuation for other patients. A Clinical Endpoint Committee (CEC) was established to perform an independent adjudication for all reported primary endpoints.
    End point type
    Primary
    End point timeframe
    Follow up of primary endpoints was performed by telephone contact with the patients or first-degree relatives by a nurse 7 days and 180 days after randomization.
    End point values
    		 Heparin-STEMI (ITT) Bivalirudin-STEMI (ITT) Heparin-NSTEMI (ITT) Bivalirudin-NSTEMI (ITT) Heparin (ITT) Bivalirudin (ITT)
    Number of subjects analysed
    1504
    1501
    1498
    1503
    3002
    3004
    Units: Events
    196
    187
    187
    182
    383
    369
    Statistical analysis title
    		 Analysis of difference of primary endpoint
    Statistical analysis description
    The hazard ratio between the bivalirudin group and the heparin group was estimated, in the ITT population, using a Cox proportional hazard model with factor randomized treatment, and presented with a 95% confidence interval. The protocol pre-defines the log-rank test, hence the equivalent score test p-value from the Cox model was used. A two-sided p-value of <0.05 is regarded as statistically significant.
    Comparison groups
    Heparin (ITT) v Bivalirudin (ITT)
    Number of subjects included in analysis
    6006
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.5362
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.1
    Notes
    [1] - 12.3% patients (369 of 3004) in the bivalirudin group and in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.10; P = 0.5362).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Registration of adverse events started at visit 1 (day 0) after informed consent and when treatment with study medication had been given and went on until day 7 after randomization into the study.
    Adverse event reporting additional description
    The following events were not collected as AE: suspected primary events or stroke, symptoms or worsening of STEMI/NSTEMI, common events in patients undergoing PCI, hospitalization in connection with PCI or planned hospitalizations, and expected AEs to heparin or bivalirudin.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD-10-SE
    Dictionary version
    2011
    Reporting groups
    Reporting group title
    Heparin
    Reporting group description
    		 Treatment with heparin i.v. alone (according to local practice) in patients with STEMI and NSTEMI treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.

    Reporting group title
    Bivalirudin
    Reporting group description
    		 Treatment with Bivalirudin 0.75 mg/kg followed by an infusion of 1.75 mg per kilogram per hour in patients with STEMI and NSTEMI treated with bolus dose of potent P2Y12 receptor inhibitors; ticagrelor, prasugrel or cangrelor before start of PCI.

    Serious adverse events
    		 Heparin Bivalirudin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 3002 (0.60%)
    11 / 3004 (0.37%)
         number of deaths (all causes)
    84
    88
         number of deaths resulting from adverse events
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm of colon, unspecified
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of gallbladder
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of bronchus and lung
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of brain, Cerebral ventricle
         subjects affected / exposed
    0 / 3002 (0.00%)
    1 / 3004 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary and unspecified malignant neoplasm of lymph nodes, Intra-abdominal lymph nodes
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary malignant neoplasm of bone and bone marrow
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    General disorders and administration site conditions
    Malaise and fatigue
         subjects affected / exposed
    0 / 3002 (0.00%)
    1 / 3004 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unspecified adverse effect of drug or medicament
         subjects affected / exposed
    0 / 3002 (0.00%)
    1 / 3004 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis due to aspiration of blood
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Postprocedural renal failure
         subjects affected / exposed
    0 / 3002 (0.00%)
    1 / 3004 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Intracardiac thrombosis, not elsewhere classified
         subjects affected / exposed
    3 / 3002 (0.10%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest, unspecified
         subjects affected / exposed
    2 / 3002 (0.07%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 3002 (0.03%)
    1 / 3004 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Syncope and collapse
         subjects affected / exposed
    1 / 3002 (0.03%)
    1 / 3004 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion (noninflammatory)
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex part
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient cerebral ischaemic attack, unspecified
         subjects affected / exposed
    0 / 3002 (0.00%)
    1 / 3004 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vestibular neuronitis
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Central retinal artery occlusion
         subjects affected / exposed
    0 / 3002 (0.00%)
    1 / 3004 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus, unspecified
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular disease of intestine, part unspecified, without perforation or abscess
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pancreatitis, unspecified
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Chronic cholecystitis
         subjects affected / exposed
    1 / 3002 (0.03%)
    0 / 3004 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Cutaneous abscess, furuncle and carbuncle, unspecified
         subjects affected / exposed
    0 / 3002 (0.00%)
    1 / 3004 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis and colitis of unspecified origin
         subjects affected / exposed
    0 / 3002 (0.00%)
    1 / 3004 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia, unspecified
         subjects affected / exposed
    0 / 3002 (0.00%)
    1 / 3004 (0.03%)
         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: 0.09%
    Non-serious adverse events
    		 Heparin Bivalirudin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 3002 (0.57%)
    19 / 3004 (0.63%)
    General disorders and administration site conditions
    Dyspnoea
         subjects affected / exposed
    2 / 3002 (0.07%)
    3 / 3004 (0.10%)
         occurrences all number
    2
    3
    Gastrointestinal disorders
    Change in bowel habit
         subjects affected / exposed
    4 / 3002 (0.13%)
    5 / 3004 (0.17%)
         occurrences all number
    4
    5
    Skin and subcutaneous tissue disorders
    Urticaria, unspecified
         subjects affected / exposed
    4 / 3002 (0.13%)
    4 / 3004 (0.13%)
         occurrences all number
    4
    4
    Rash and other nonspecific skin eruption
         subjects affected / exposed
    1 / 3002 (0.03%)
    3 / 3004 (0.10%)
         occurrences all number
    1
    3
    Endocrine disorders
    Unspecified diabetes mellitus
         subjects affected / exposed
    3 / 3002 (0.10%)
    4 / 3004 (0.13%)
         occurrences all number
    3
    4
    Type 2 diabetes mellitus
         subjects affected / exposed
    3 / 3002 (0.10%)
    0 / 3004 (0.00%)
         occurrences all number
    3
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jan 2013
    Amendment 1 included minor administrative changes to the protocol.
    15 Feb 2014
    Amendment 3 included minor administrative changes to the protocol. Note that Amendment 2 was rejected by the regulatory authority and was not implemented.
    17 Oct 2014
    In Amendment 4, the following secondary outcome variables were added: • The primary endpoint combined with stroke (added post-FPI, Amendment IV, 2014-10-17) • Bail-out use of GpIIb/IIIa inhibitors during PCI (added post-FPI, Amendment IV, 2014-10-17)
    06 Jul 2015
    In Amendment 5, the following secondary outcome variable was updated : • Time to subtypes of reinfarction as reported in by CEC (1, 2, 3, 4a, 4b, 5). (Added post-FPI, Amendment V, 2015-07-06, although adjudication of infarction types was planned in the first version of the Clinical Endpoint Committee (CEC) Charter (dated 2014-12-18), the protocol, by mistake, states time to “rehospitalization with” subtypes of myocardial infarction (MI), but the CEC does not adjudicate rehospitalization, only MI).

    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.
    Note that age data is missing for 7 patients. In the results reported for "Subjects enrolled per age group", these patients are included in the most common age group (Adults 65-84y).

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28844201
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