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    Clinical Trial Results:
    A Randomized, Double-Blind, Active-Controlled Trial to Evaluate Intravenous and Oral PRT060128, a Selective and Reversible P2Y12-Receptor Inhibitor, vs. Clopidogrel, as a Novel Antiplatelet Therapy in Patients Undergoing Non-Urgent Percutaneous Coronary Interventions (INNOVATE-PCI)

    Summary
    EudraCT number
    2008-001352-51
    Trial protocol
    DE   AT  
    Global end of trial date
    02 Apr 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    07-116
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Portola Pharmaceuticals, Inc.
    Sponsor organisation address
    270 East Grand Avenue, South San Francisco, United States, 94080
    Public contact
    Susanne Fors, Portola Pharmaceuticals, 001 650-246-7649, sfors@portola.com
    Scientific contact
    Susanne Fors, Portola Pharmaceuticals, 001 650-246-7649, sfors@portola.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jan 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Apr 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a Phase 2 study to evaluate the clinical efficacy, safety, and tolerability of intravenous (IV) and oral elinogrel (previously known as PRT060128) in patients undergoing non-urgent percutaneous coronary intervention (PCI).
    Protection of trial subjects
    The protocol and informed consent form (ICF) for this study were reviewed and approved by an appropriate institutional review board (IRB)/research ethics board (REB)/independent ethics committee (IEC) before patients were randomized in the study. This study was designed, conducted, recorded, and reported in compliance with the principles set forth in the Declaration of Helsinki and with ICH guidelines. These guidelines are stated in U.S. federal regulations as well as in ―Guidance for Good Clinical Practice, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Nov 2008
    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
    Poland: 74
    Country: Number of subjects enrolled
    Austria: 28
    Country: Number of subjects enrolled
    Germany: 126
    Country: Number of subjects enrolled
    Canada: 132
    Country: Number of subjects enrolled
    United States: 292
    Worldwide total number of subjects
    652
    EEA total number of subjects
    228
    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)
    416
    From 65 to 84 years
    236
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    After a diagnostic angiography, eligible patients scheduled for non-urgent PCI were randomized, study drug was initiated, and the PCI was performed.

    Pre-assignment
    Screening details
    1. The patient was scheduled to undergo non-urgent PCI. 2. The patient was between 18 and 75 years of age (inclusive) and willing to comply with the protocol

    Period 1
    Period 1 title
    Patient Disposition (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    300/600mg Clopidogrel
    Arm description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)
    Arm type
    Active comparator

    Investigational medicinal product name
    Clopidogrel
    Investigational medicinal product code
    Other name
    Plavix
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Loading dose of 300mg or 600mg

    Arm title
    80mg IV + 50mg PO Elinogrel
    Arm description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)
    Arm type
    Experimental

    Investigational medicinal product name
    Elinogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    80-120mg IV bolus administered prior to PCI, followed by twice daily doing of oral 50mg, 100mg or 150mg

    Investigational medicinal product name
    Elinogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    80-120mg IV bolus administered prior to PCI, followed by twice daily doing of oral 50mg, 100mg or 150mg

    Arm title
    80mg IV + 100mg PO Elinogrel
    Arm description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)
    Arm type
    Experimental

    Investigational medicinal product name
    Elinogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    80-120mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg

    Investigational medicinal product name
    Elinogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    80-120mg IV bolus administered prior to PCI, followed by twice daily doing of oral 50mg, 100mg or 150mg

    Arm title
    80mg IV + 150mg PO Elinogrel
    Arm description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)
    Arm type
    Experimental

    Investigational medicinal product name
    Elinogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    80-120 mg IV bolus administered prior to PCI, followed by twice daily doing of oral 50mg, 100mg or 150mg

    Investigational medicinal product name
    Elinogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    80-120mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg

    Arm title
    120mg IV + 100mg PO Elinogrel
    Arm description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)
    Arm type
    Experimental

    Investigational medicinal product name
    Elinogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    80-120mg IV bolus administered prior to PCI, followed by twice daily doing of oral 50mg, 100mg or 150mg

    Investigational medicinal product name
    Elinogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    80-120mg IV bolus administered prior to PCI, followed by twice daily doing of oral 50mg, 100mg or 150mg

    Arm title
    120mg IV + 150mg PO Elinogrel
    Arm description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)
    Arm type
    Experimental

    Investigational medicinal product name
    Elinogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    80-120mg IV bolus administered prior to PCI, followed by twice daily doing of oral 50mg, 100mg or 150mg

    Investigational medicinal product name
    Elinogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    80-120mg IV bolus administered prior to PCI, followed by twice daily doing of oral 50mg, 100mg or 150mg

    Number of subjects in period 1
    300/600mg Clopidogrel 80mg IV + 50mg PO Elinogrel 80mg IV + 100mg PO Elinogrel 80mg IV + 150mg PO Elinogrel 120mg IV + 100mg PO Elinogrel 120mg IV + 150mg PO Elinogrel
    Started
    212
    26
    50
    47
    154
    163
    Completed
    154
    21
    32
    29
    109
    113
    Not completed
    58
    5
    18
    18
    45
    50
         Adverse event, serious fatal
    -
    -
    -
    -
    1
    -
         Physician decision
    1
    -
    -
    -
    1
    2
         Consent withdrawn by subject
    8
    -
    2
    -
    4
    6
         Adverse event, non-fatal
    15
    3
    5
    6
    8
    11
         Visit prior to visit Time Window
    24
    2
    6
    6
    22
    18
         not including Adverse Event
    3
    -
    2
    1
    3
    6
         Lost to follow-up
    -
    -
    -
    2
    -
    2
         Missing
    3
    -
    2
    1
    4
    4
         Did Not Receive Treatment
    4
    -
    1
    2
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    300/600mg Clopidogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    80mg IV + 50mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    80mg IV + 100mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    80mg IV + 150mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    120mg IV + 100mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    120mg IV + 150mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group values
    300/600mg Clopidogrel 80mg IV + 50mg PO Elinogrel 80mg IV + 100mg PO Elinogrel 80mg IV + 150mg PO Elinogrel 120mg IV + 100mg PO Elinogrel 120mg IV + 150mg PO Elinogrel Total
    Number of subjects
    212 26 50 47 154 163 652
    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)
    60.9 ( 8.53 ) 61.4 ( 8.84 ) 60.6 ( 8.45 ) 58.3 ( 9.88 ) 60.7 ( 8.81 ) 60.6 ( 8.73 ) -
    Gender categorical
    Units: Subjects
        Female
    50 6 9 8 38 38 149
        Male
    162 20 41 39 116 125 503

    End points

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    End points reporting groups
    Reporting group title
    300/600mg Clopidogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    80mg IV + 50mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    80mg IV + 100mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    80mg IV + 150mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    120mg IV + 100mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    120mg IV + 150mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Subject analysis set title
    Intention-to-Treat Population
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All patients randomized regardless of whether or not treatment was received

    Subject analysis set title
    Efficacy Population
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    All patients who were randomized, received any study medication and the Index PCI

    Subject analysis set title
    Safety Population
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All patients who were randomized and received any study medication

    Primary: Composite of death, myocardial infarction (MI), stroke, and urgent target vessel revascularization (UTVR)

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    End point title
    Composite of death, myocardial infarction (MI), stroke, and urgent target vessel revascularization (UTVR) [1]
    End point description
    Clinical Efficacy Endpoint
    End point type
    Primary
    End point timeframe
    From initial treatment with study drug (Treatment) to 24 Hours or Discharge (whichever occurred first)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The study was an exploratory study and not powered for a statistical evaluation of endpoints. No hypotheses-driven statistical analyses were performed; data are presented using descriptive statistics.
    End point values
    300/600mg Clopidogrel 80mg IV + 50mg PO Elinogrel 80mg IV + 100mg PO Elinogrel 80mg IV + 150mg PO Elinogrel 120mg IV + 100mg PO Elinogrel 120mg IV + 150mg PO Elinogrel
    Number of subjects analysed
    208
    26
    48
    44
    152
    160
    Units: Number of Participants
    10
    3
    5
    1
    11
    14
    No statistical analyses for this end point

    Secondary: Composite of death, MI, stroke, UTVR, and stent thrombosis

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    End point title
    Composite of death, MI, stroke, UTVR, and stent thrombosis
    End point description
    Clinical Efficacy Endpoint
    End point type
    Secondary
    End point timeframe
    From initial treatment with study drug (Treatment) to 24 Hours or Discharge (whichever occurred first)
    End point values
    300/600mg Clopidogrel 80mg IV + 50mg PO Elinogrel 80mg IV + 100mg PO Elinogrel 80mg IV + 150mg PO Elinogrel 120mg IV + 100mg PO Elinogrel 120mg IV + 150mg PO Elinogrel
    Number of subjects analysed
    208
    26
    48
    44
    152
    160
    Units: Number of Participants
    10
    3
    5
    1
    11
    14
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomization to 7 days after the last received dose
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    300/600mg Clopidogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    80mg IV + 50mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    80mg IV + 100mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    80mg IV + 150mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    120mg IV + 100mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Reporting group title
    120mg IV + 150mg PO Elinogrel
    Reporting group description
    Intention-to-Treat Population (all patients randomized regardless of whether or not treatment was received)

    Serious adverse events
    300/600mg Clopidogrel 80mg IV + 50mg PO Elinogrel 80mg IV + 100mg PO Elinogrel 80mg IV + 150mg PO Elinogrel 120mg IV + 100mg PO Elinogrel 120mg IV + 150mg PO Elinogrel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 208 (11.06%)
    4 / 26 (15.38%)
    8 / 49 (16.33%)
    3 / 47 (6.38%)
    22 / 152 (14.47%)
    23 / 160 (14.38%)
         number of deaths (all causes)
    0
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer stage II
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma stage I
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic stenosis
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    4 / 208 (1.92%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    2 / 160 (1.25%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    2 / 49 (4.08%)
    1 / 47 (2.13%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    2 / 160 (1.25%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    3 / 160 (1.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Facial bones fracture
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural myocardial infarction
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 208 (0.96%)
    1 / 26 (3.85%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 208 (0.96%)
    1 / 26 (3.85%)
    2 / 49 (4.08%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    3 / 160 (1.88%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    4 / 160 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 26 (3.85%)
    0 / 49 (0.00%)
    1 / 47 (2.13%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery perforation
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    1 / 49 (2.04%)
    1 / 47 (2.13%)
    3 / 152 (1.97%)
    4 / 160 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    1 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystles
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    1 / 47 (2.13%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Groin pain
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial infection
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    2 / 160 (1.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 26 (3.85%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 208 (0.00%)
    1 / 26 (3.85%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 208 (0.00%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    0 / 47 (0.00%)
    1 / 152 (0.66%)
    0 / 160 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    300/600mg Clopidogrel 80mg IV + 50mg PO Elinogrel 80mg IV + 100mg PO Elinogrel 80mg IV + 150mg PO Elinogrel 120mg IV + 100mg PO Elinogrel 120mg IV + 150mg PO Elinogrel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    122 / 208 (58.65%)
    17 / 26 (65.38%)
    34 / 49 (69.39%)
    34 / 47 (72.34%)
    91 / 152 (59.87%)
    107 / 160 (66.88%)
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 208 (0.48%)
    0 / 26 (0.00%)
    2 / 49 (4.08%)
    3 / 47 (6.38%)
    3 / 152 (1.97%)
    3 / 160 (1.88%)
         occurrences all number
    1
    0
    2
    3
    3
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    12 / 208 (5.77%)
    2 / 26 (7.69%)
    3 / 49 (6.12%)
    2 / 47 (4.26%)
    6 / 152 (3.95%)
    7 / 160 (4.38%)
         occurrences all number
    20
    2
    3
    2
    6
    10
    Vascular disorders
    Haematoma
         subjects affected / exposed
    7 / 208 (3.37%)
    1 / 26 (3.85%)
    1 / 49 (2.04%)
    3 / 47 (6.38%)
    6 / 152 (3.95%)
    9 / 160 (5.63%)
         occurrences all number
    8
    1
    1
    3
    7
    9
    Hypertension
         subjects affected / exposed
    4 / 208 (1.92%)
    0 / 26 (0.00%)
    0 / 49 (0.00%)
    3 / 47 (6.38%)
    1 / 152 (0.66%)
    3 / 160 (1.88%)
         occurrences all number
    4
    0
    0
    3
    1
    4
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    15 / 208 (7.21%)
    1 / 26 (3.85%)
    5 / 49 (10.20%)
    2 / 47 (4.26%)
    6 / 152 (3.95%)
    5 / 160 (3.13%)
         occurrences all number
    17
    1
    5
    2
    6
    6
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 208 (3.37%)
    1 / 26 (3.85%)
    0 / 49 (0.00%)
    2 / 47 (4.26%)
    5 / 152 (3.29%)
    8 / 160 (5.00%)
         occurrences all number
    8
    1
    0
    2
    5
    8
    Headache
         subjects affected / exposed
    8 / 208 (3.85%)
    1 / 26 (3.85%)
    4 / 49 (8.16%)
    4 / 47 (8.51%)
    3 / 152 (1.97%)
    8 / 160 (5.00%)
         occurrences all number
    8
    1
    5
    4
    3
    9
    General disorders and administration site conditions
    Catheter site haematoma
         subjects affected / exposed
    5 / 208 (2.40%)
    1 / 26 (3.85%)
    3 / 49 (6.12%)
    2 / 47 (4.26%)
    5 / 152 (3.29%)
    14 / 160 (8.75%)
         occurrences all number
    6
    1
    3
    2
    5
    14
    Catheter site haemorrhage
         subjects affected / exposed
    4 / 208 (1.92%)
    5 / 26 (19.23%)
    3 / 49 (6.12%)
    1 / 47 (2.13%)
    6 / 152 (3.95%)
    2 / 160 (1.25%)
         occurrences all number
    4
    5
    3
    1
    6
    2
    Fatigue
         subjects affected / exposed
    8 / 208 (3.85%)
    0 / 26 (0.00%)
    3 / 49 (6.12%)
    1 / 47 (2.13%)
    2 / 152 (1.32%)
    4 / 160 (2.50%)
         occurrences all number
    8
    0
    3
    1
    2
    4
    Non-cardiac chest pain
         subjects affected / exposed
    7 / 208 (3.37%)
    2 / 26 (7.69%)
    0 / 49 (0.00%)
    2 / 47 (4.26%)
    7 / 152 (4.61%)
    5 / 160 (3.13%)
         occurrences all number
    8
    2
    0
    2
    8
    5
    Chest discomfort
         subjects affected / exposed
    3 / 208 (1.44%)
    3 / 26 (11.54%)
    4 / 49 (8.16%)
    3 / 47 (6.38%)
    1 / 152 (0.66%)
    3 / 160 (1.88%)
         occurrences all number
    3
    3
    4
    3
    1
    3
    Chest pain
         subjects affected / exposed
    4 / 208 (1.92%)
    0 / 26 (0.00%)
    4 / 49 (8.16%)
    0 / 47 (0.00%)
    6 / 152 (3.95%)
    7 / 160 (4.38%)
         occurrences all number
    4
    0
    4
    0
    6
    7
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 208 (1.92%)
    2 / 26 (7.69%)
    0 / 49 (0.00%)
    3 / 47 (6.38%)
    0 / 152 (0.00%)
    3 / 160 (1.88%)
         occurrences all number
    4
    2
    0
    4
    0
    4
    Gingival bleeding
         subjects affected / exposed
    2 / 208 (0.96%)
    2 / 26 (7.69%)
    1 / 49 (2.04%)
    0 / 47 (0.00%)
    0 / 152 (0.00%)
    0 / 160 (0.00%)
         occurrences all number
    2
    3
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    9 / 208 (4.33%)
    1 / 26 (3.85%)
    1 / 49 (2.04%)
    1 / 47 (2.13%)
    5 / 152 (3.29%)
    8 / 160 (5.00%)
         occurrences all number
    11
    1
    2
    1
    5
    9
    Vomiting
         subjects affected / exposed
    4 / 208 (1.92%)
    2 / 26 (7.69%)
    1 / 49 (2.04%)
    1 / 47 (2.13%)
    1 / 152 (0.66%)
    2 / 160 (1.25%)
         occurrences all number
    4
    2
    1
    1
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    8 / 208 (3.85%)
    1 / 26 (3.85%)
    9 / 49 (18.37%)
    3 / 47 (6.38%)
    16 / 152 (10.53%)
    22 / 160 (13.75%)
         occurrences all number
    8
    1
    11
    3
    19
    23
    Epistaxis
         subjects affected / exposed
    6 / 208 (2.88%)
    1 / 26 (3.85%)
    1 / 49 (2.04%)
    2 / 47 (4.26%)
    12 / 152 (7.89%)
    8 / 160 (5.00%)
         occurrences all number
    7
    1
    1
    2
    14
    9
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 208 (0.48%)
    2 / 26 (7.69%)
    1 / 49 (2.04%)
    1 / 47 (2.13%)
    0 / 152 (0.00%)
    1 / 160 (0.63%)
         occurrences all number
    1
    2
    1
    1
    0
    1
    Back pain
         subjects affected / exposed
    13 / 208 (6.25%)
    1 / 26 (3.85%)
    3 / 49 (6.12%)
    0 / 47 (0.00%)
    7 / 152 (4.61%)
    3 / 160 (1.88%)
         occurrences all number
    14
    1
    3
    0
    7
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Apr 2009
    1. For patients requiring repeat (elective or urgent) revascularization during the study, reloading the patient with elinogrel/placebo IV bolus (Kit A ±X) and the clopidogrel/placebo loading dose (Kit C) should be performed. 2. To ensure consistent antiplatelet coverage during the transition to open-label therapy at the end of study participation, a regimen for clopidogrel reloading was recommended. 3. The timing of the second oral dose of elinogrel (Kit B) was updated to ensure that patients receive their second dose in the evening of their index PCI. 4. The treatment period for chronic oral dosing was extended from 60 days to 120 days; patients who are currently active on the study at the time of approval of the amendment will have the option to sign a new consent form in order to participate for the extended period of 120 days. Corresponding Day 120 endpoints were added to assess efficacy and safety. 5. An administrative interim analysis after all patients have completed the first 60 days of treatment was added. 6. Inclusion criterion #3 was modified to require two forms of contraception, one of which must consist of oral or injected contraceptives, transdermal hormone patch, subdermal implants, IUD with hormones or copper, or surgical sterilization. 7. Exclusion criterion #11 regarding administration of thrombolytic agents, fondaparinux, or oral anticoagulants (e.g., warfarin) within the 7 days prior to PCI was modified to also exclude patients with a requirement for chronic oral anticoagulation. 8. At the recommendation of the DSMC, the 50 mg dose level was dropped from randomization on April 8, 2009.

    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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