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    Clinical Trial Results:
    A Randomized, Open-Label, Multi-Center, Active-Controlled, Parallel Group Study to Determine the Efficacy and Safety of the REG1 Anticoagulation System Compared to Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention

    Summary
    EudraCT number
    		 2013-001384-23
    Trial protocol
    		 HU   EE   DE   NL   PT   AT   GB   IT   BE   SK   ES   DK   PL   CZ   FR  
    Global end of trial date
    01 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Aug 2019
    First version publication date
    23 Aug 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    REG1-CLIN310
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01848106
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regado Biosciences, Inc
    Sponsor organisation address
    Clonshaugh Business and Technology Park, Coolock, Dublin, Ireland, D17 E400
    Public contact
    Clinical Trials Registry Team, Allergan plc, 001 877‐277‐8566, IR-CTRegistration@Allergan.com
    Scientific contact
    Therapeutic Area Head, Allergan plc, 001 862-261-7000, IR-CTRegistration@Allergan.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
    29 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to determine the efficacy of REG1 compared to bivalirudin in participants with coronary artery disease (CAD) undergoing Percutaneous Coronary Intervention (PCI) for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent target lesion revascularization (TLR) through Day 3 post randomisation.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 All participants were to receive an initial dose of aspirin in addition to loading and maintenance doses of an ADP/P2Y12 inhibitor (dose and timing per local standard of care); administration of these medications prior to randomization and start of PCI.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 2253
    Country: Number of subjects enrolled
    United Kingdom: 979
    Worldwide total number of subjects
    3232
    EEA total number of subjects
    979
    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)
    1616
    From 65 to 84 years
    1616
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 3232 participants were enrolled and randomised from 325 centres.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Reg 1 (Pegnivacogin/Anivamersen)
    Arm description
    		 Pegnivacogin 1.0 mg/kg, intravenous (IV) bolus injection or arterial sheath prior to the PCI. Anivamersen 0.5 mg/kg (80% reversal), IV bolus injection after PCI.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pegnivacogin/Anivamersen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pegnivacogin 1.0 mg/kg, intravenous (IV) bolus injection or arterial sheath prior to the PCI. Anivamersen 0.5 mg/kg (80% reversal), IV bolus injection after PCI.

    Arm title
    		 Bivalirudin
    Arm description
    		 Bivalirudin 0.75 mg/kg IV bolus injection or arterial sheath prior to PCI, immediately followed by an IV infusion of 1.75 mg/kg/hour until completion of PCI.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bivalirudin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Bivalirudin 0.75 mg/kg IV bolus injection or arterial sheath prior to PCI, immediately followed by an IV infusion of 1.75 mg/kg/hour until completion of PCI.

    Number of subjects in period 1
    		Reg 1 (Pegnivacogin/Anivamersen) Bivalirudin
    Started
    1616
    1616
    Completed
    1613
    1608
    Not completed
    3
    8
         Withdrew Consent
    -
    2
         Unknown
    -
    1
         Unable to Contact
    3
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Reg 1 (Pegnivacogin/Anivamersen)
    Reporting group description
    		 Pegnivacogin 1.0 mg/kg, intravenous (IV) bolus injection or arterial sheath prior to the PCI. Anivamersen 0.5 mg/kg (80% reversal), IV bolus injection after PCI.

    Reporting group title
    Bivalirudin
    Reporting group description
    		 Bivalirudin 0.75 mg/kg IV bolus injection or arterial sheath prior to PCI, immediately followed by an IV infusion of 1.75 mg/kg/hour until completion of PCI.

    Reporting group values
    		 Reg 1 (Pegnivacogin/Anivamersen) Bivalirudin Total
    Number of subjects
    		 1616 1616 3232
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.4 ± 10.68 65.2 ± 10.73 -
    Gender Categorical
    Units: Subjects
        Female
    		 401 432 833
        Male
    		 1215 1184 2399

    End points

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    End points reporting groups
    Reporting group title
    Reg 1 (Pegnivacogin/Anivamersen)
    Reporting group description
    		 Pegnivacogin 1.0 mg/kg, intravenous (IV) bolus injection or arterial sheath prior to the PCI. Anivamersen 0.5 mg/kg (80% reversal), IV bolus injection after PCI.

    Reporting group title
    Bivalirudin
    Reporting group description
    		 Bivalirudin 0.75 mg/kg IV bolus injection or arterial sheath prior to PCI, immediately followed by an IV infusion of 1.75 mg/kg/hour until completion of PCI.

    Subject analysis set title
    Subgroup A
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subgroup A included participants who had acute coronary syndrome with positive cardiac biomarkers within the previous 7 days before enrollment.

    Subject analysis set title
    Subgroup B and C
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subgroup B included participants who had acute coronary syndrome with positive biomarkers more than 7 days before enrollment, had unstable angina without positive biomarkers, were older than 70 years, had diabetes or chronic kidney disease, had planned multivessel percutaneous coronary intervention, had undergone previous coronary artery bypass graft (CABG) surgery, or had peripheral vascular disease. Subgroup C included participants not meeting criteria for subgroups A or B.

    Primary: Number of Participants With at Least 1 of the Composite Events of Death, Non-Fatal MI, Non-Fatal Stroke and UTLR Through Day 3 Post Randomization: CEC Adjudicated Data

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    End point title
    		 Number of Participants With at Least 1 of the Composite Events of Death, Non-Fatal MI, Non-Fatal Stroke and UTLR Through Day 3 Post Randomization: CEC Adjudicated Data
    End point description
    Clinical Events Committee (CEC) Adjudicated Data is provided for the composite of events of Death, Non-Fatal Myocardial Infarction (MI), Non-fatal Stroke and Urgent Target Lesion Revascularization (UTLR). Intent-to-treat (ITT) population included all randomised participants. Number analysed is the number of participants with complete follow up information through Day 3.
    End point type
    Primary
    End point timeframe
    Baseline (Day 0 prior to PCI) to Day 3 post randomisation
    End point values
    		 Reg 1 (Pegnivacogin/Anivamersen) Bivalirudin
    Number of subjects analysed
    1615
    1613
    Units: participants
        Death
    2
    5
        MI
    103
    93
        Stroke
    1
    3
        Urgent TLR
    4
    8
    Statistical analysis title
    		 Death
    Comparison groups
    Reg 1 (Pegnivacogin/Anivamersen) v Bivalirudin
    Number of subjects included in analysis
    3228
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2556
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 2.06
    Statistical analysis title
    		 MI
    Comparison groups
    Reg 1 (Pegnivacogin/Anivamersen) v Bivalirudin
    Number of subjects included in analysis
    3228
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4673
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.49
    Statistical analysis title
    		 Stroke
    Comparison groups
    Reg 1 (Pegnivacogin/Anivamersen) v Bivalirudin
    Number of subjects included in analysis
    3228
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3168
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 3.2
    Statistical analysis title
    		 Urgent TLR
    Comparison groups
    Reg 1 (Pegnivacogin/Anivamersen) v Bivalirudin
    Number of subjects included in analysis
    3228
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2466
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.15
         upper limit
    		 1.66

    Secondary: Number of Participants with at Least 1 of the Composite Events of Death, Non-fatal MI, Non-fatal Stroke, UTLR, and Stent Thrombosis (including Intraprocedural) through Day 3: CEC Adjudicated Data

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    End point title
    		 Number of Participants with at Least 1 of the Composite Events of Death, Non-fatal MI, Non-fatal Stroke, UTLR, and Stent Thrombosis (including Intraprocedural) through Day 3: CEC Adjudicated Data
    End point description
    CEC Adjudicated Data is provided for the composite of events of Death, Non-Fatal MI, Non-fatal Stroke and UTLR and Stent Thrombosis. ITT population included all randomised participants. Number analysed is the number of participants with complete follow up information through Day 3.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0 prior to PCI) to Day 3 post randomisation
    End point values
    		 Reg 1 (Pegnivacogin/Anivamersen) Bivalirudin
    Number of subjects analysed
    1615
    1613
    Units: participants
    108
    103
    No statistical analyses for this end point

    Secondary: Number of Participants with Major Non-Coronary Artery Bypass Graft (CABG) Bleeding [Bleeding Academic Research Consortium (BARC) Types 3 and 5] Through Day 3: CEC Adjudicated Data

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    End point title
    		 Number of Participants with Major Non-Coronary Artery Bypass Graft (CABG) Bleeding [Bleeding Academic Research Consortium (BARC) Types 3 and 5] Through Day 3: CEC Adjudicated Data
    End point description
    BARC criteria for bleeding include 5 types ranging from 1=bleeding is not actionable to 5=fatal bleeding. Type 3 bleeding: 3a=hemoglobin drop of 3 to 5 g/dL, transfusion of packed red blood cells or whole blood; 3b= hemoglobin drop>=5 g/dL, cardiac tamponade, requiring surgical intervention, requiring intravenous vasoactive agents; 3c=intracranial hemorrhage, Intraocular bleeding. Type 5 fatal bleeding: 5a=probable fatal clinically suspicious; 5 b=fatal confirmed by autopsy or imaging. Safety population included all participants who were randomised and received at least one dose of study drug. Number analysed is the number of participants with complete follow up information through Day 3.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0 prior to PCI) to Day 3 post randomisation
    End point values
    		 Reg 1 (Pegnivacogin/Anivamersen) Bivalirudin
    Number of subjects analysed
    1603
    1600
    Units: participants
    7
    2
    No statistical analyses for this end point

    Secondary: Number of Participants with at Least 1 of the Composite Events of Death, Non-fatal MI, Non-fatal stroke, and UTLR through Day 30: CEC Adjudicated Data

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    End point title
    		 Number of Participants with at Least 1 of the Composite Events of Death, Non-fatal MI, Non-fatal stroke, and UTLR through Day 30: CEC Adjudicated Data
    End point description
    CEC Adjudicated Data is provided for the composite of events of Death, Non-Fatal MI, Non-fatal Stroke and UTLR and. ITT population included all randomised participants. Number analysed is the number of participants with complete follow up information through Day 30.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0 prior to PCI) to Day 30 post randomisation
    End point values
    		 Reg 1 (Pegnivacogin/Anivamersen) Bivalirudin
    Number of subjects analysed
    1613
    1608
    Units: participants
    122
    122
    No statistical analyses for this end point

    Secondary: Number of Participants with at Least 1 of the Composite Events of Death, Non-fatal MI, Non-fatal Stroke, and UTLR through Day 3 in Subgroup A

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    End point title
    		 Number of Participants with at Least 1 of the Composite Events of Death, Non-fatal MI, Non-fatal Stroke, and UTLR through Day 3 in Subgroup A
    End point description
    Subgroup A included participants with ischemic symptoms at rest and positive cardiac biomarkers (troponin I or T or creatine kinase-MB) related to an acute coronary syndrome (ACS) event.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0 prior to PCI) through Day 3 post randomisation
    End point values
    		 Subgroup A
    Number of subjects analysed
    493
    Units: participants
    42
    No statistical analyses for this end point

    Secondary: Number of Participants with at Least 1 of the Composite Events of Death, Non-fatal MI, Non-fatal Stroke and UTLR through Day 3 in Subgroups B and C (Negative Cardiac Biomarkers)

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    End point title
    		 Number of Participants with at Least 1 of the Composite Events of Death, Non-fatal MI, Non-fatal Stroke and UTLR through Day 3 in Subgroups B and C (Negative Cardiac Biomarkers)
    End point description
    Subgroups B and C participants not meeting criteria for Subgroup A.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0 prior to PCI) through Day 3 post randomisation
    End point values
    		 Subgroup B and C
    Number of subjects analysed
    2739
    Units: participants
    169
    No statistical analyses for this end point

    Secondary: Number of Participants with Major Non-CABG bleeding (BARC Types 3 and 5) through Day 30: CEC Adjudicated Data

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    End point title
    		 Number of Participants with Major Non-CABG bleeding (BARC Types 3 and 5) through Day 30: CEC Adjudicated Data
    End point description
    BARC criteria for bleeding include 5 types ranging from 1=bleeding is not actionable to 5=fatal bleeding. Type 3 bleeding: 3a=hemoglobin drop of 3 to 5 g/dL, transfusion of packed red blood cells or whole blood; 3b= hemoglobin drop>=5 g/dL, cardiac tamponade, requiring surgical intervention, requiring intravenous vasoactive agents; 3c=intracranial hemorrhage, Intraocular bleeding. Type 5 fatal bleeding: 5a=probable fatal clinically suspicious; 5 b=fatal confirmed by autopsy or imaging. Safety population included all participants who were randomised and received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 0 prior to PCI) through Day 30 post randomisation
    End point values
    		 Reg 1 (Pegnivacogin/Anivamersen) Bivalirudin
    Number of subjects analysed
    1601
    1596
    Units: participants
    11
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Randomisation through 3 days post-randomisation for Adverse Events (AEs) and Randomisation through 30 days post-randomisation for Serious Adverse Events (SAEs) [Up to Day 35]
    Adverse event reporting additional description
    Events that met efficacy and bleeding endpoint criteria were not considered AEs or SAEs. In addition, pre-defined disease-related and procedural-related events were not considered AEs or SAEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Reg 1 (Pegnivacogin/Anivamersen)
    Reporting group description
    		 Pegnivacogin administered by a bolus injection of 1.0 mg/kg over approximately 2 minutes, IV or arterial sheath prior to the PCI procedure. Anivamersen was administered at 0.5 mg/kg (80% reversal), IV bolus injection over approximately 1 minute upon completion of the PCI procedure.

    Reporting group title
    Bivalirudin
    Reporting group description
    		 Bivalirudin administered by a bolus injection of 0.75 mg/kg IV or arterial sheath prior to the PCI procedure, immediately followed by an IV infusion of 1.75 mg/kg/hour until completion of the procedure (infusion rate adjusted for renal insufficient participants per the local bivalirudin label).

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no non-serious adverse events at the 5% frequency threshold for reporting.
    Serious adverse events
    		 Reg 1 (Pegnivacogin/Anivamersen) Bivalirudin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    29 / 1605 (1.81%)
    13 / 1601 (0.81%)
         number of deaths (all causes)
    8
    12
         number of deaths resulting from adverse events
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Post-traumatic pain
         subjects affected / exposed
    0 / 1605 (0.00%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (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
    Convulsion
         subjects affected / exposed
    0 / 1605 (0.00%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    6 / 1605 (0.37%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    5 / 6
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    4 / 1605 (0.25%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 1605 (0.00%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 1605 (0.00%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 1605 (0.12%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 1605 (0.06%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 1605 (0.00%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pleural effusion
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    0 / 1605 (0.00%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Incision site infection
         subjects affected / exposed
    0 / 1605 (0.00%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 1605 (0.00%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 1605 (0.00%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 1605 (0.06%)
    2 / 1601 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thrombophlebitis septic
         subjects affected / exposed
    0 / 1605 (0.00%)
    1 / 1601 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinea pedis
         subjects affected / exposed
    1 / 1605 (0.06%)
    0 / 1601 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Reg 1 (Pegnivacogin/Anivamersen) Bivalirudin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1605 (0.00%)
    0 / 1601 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jan 2014
    The following changes were done as per Amendment 1: Protocol amendment was done primarily in response to health authority feedback requesting stronger wording about males who could father a child during study participation and women who may be nursing during study participation. Stronger wording was added related to both of these special participant circumstances. Clarified 2 of the 8 possible risk factors used to define Subgroup B of participants − The risk factor, “Remote acute coronary syndrome (> 7 days) with positive cardiac biomarkers” was changed to “Current presentation with an acute coronary syndrome with positive biomarkers > 7 days prior to randomization.” − The risk factor “Unstable angina (ACS without positive cardiac biomarkers)” became “Current presentation with unstable angina (ACS without positive cardiac biomarkers).” Changed the required time interval between randomization and any planned staged PCI procedure (post index PCI) so that staged PCI was excluded if planned within 30 days, rather than within 3 days, after randomization. Clarified that all participants were to receive dual antiplatelet therapy for the duration of the study; and clarified recommendations for the use of aspirin and ADP/P2Y12 inhibitors and the protocol restriction of GP IIb/IIIa inhibitors to only provisional use for procedural or angiographic complications. Clarified that “post dosing” window of time for laboratory testing referred to post bivalirudin bolus dose or post pegnivacogin dose, and not to anivamersen dose.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    29 Jun 2014
    The study was terminated for safety reasons on 29 June 2014 and was put on FDA clinical hold on 9 July 2014.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    In order to submit summary results, estimated data was entered in the Trial Information Age and Country fields. Due to acquisition, the sponsor does not have access to detailed demographic information. More information: (PubMed ID: 26547100).

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26547100
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