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    Clinical Trial Results:
    A Phase 2, Placebo Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of BMS- 986141 For the Prevention of Recurrent Brain Infarction in Subjects Receiving Acetylsalicylic Acid (ASA) Following Acute Ischemic Stroke or Transient Ischemic Attack

    Summary
    EudraCT number
    		 2015-003959-22
    Trial protocol
    		 ES  
    Global end of trial date
    31 Mar 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    27 Oct 2018
    First version publication date
    15 Apr 2018
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    CV006-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02671461
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    31 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the dose-response relationship of BMS-986141 on the recurrence of brain infarction at 28 days as assessed by a composite of symptomatic ischemic stroke and unrecognized brain infarction as assessed by MRI in subjects with ischemic stroke or TIA treated with ASA.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Sep 2016
    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: 16
    Worldwide total number of subjects
    16
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    10
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 16 subjects were enrolled; 15 were randomized, and 14 subjects were treated and included in final data analysis. 1 subject was not randomized because the interactive voice response system did not work at the time of enrollment; 1 consent withdrawn by subject

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching Placebo for BMS-986141 QD for up to 28 days

    Arm title
    		 BMS-986141 0.8 mg
    Arm description
    		 BMS-986141 0.8 mg QD for up to 28 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986141
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.8 mg BMS-986141 QD for up to 28 days

    Arm title
    		 BMS-986141 4.8 mg
    Arm description
    		 BMS-986141 4.8 mg QD for up to 28 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-986141
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    4.8 mg BMS-986141 QD for up to 28 days

    Number of subjects in period 1 [1]
    		Placebo BMS-986141 0.8 mg BMS-986141 4.8 mg
    Started
    2
    5
    7
    Completed Treatment Period
    1
    2 [2]
    2 [3]
    Completed
    1
    4
    6
    Not completed
    1
    1
    1
         Consent withdrawn by subject
    1
    -
    -
         Lost to follow-up
    -
    -
    1
         Administrative Reason by Sponsor
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 16 subjects were enrolled; 15 were randomized, and 14 subjects were treated and included in final data analysis. 1 subject was not randomized because the interactive voice response system did not work at the time of enrollment; 1 consent withdrawn by subject.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 16 subjects were enrolled; 15 were randomized, and 14 subjects were treated and included in final data analysis. 1 subject was not randomized because the interactive voice response system did not work at the time of enrollment; 1 consent withdrawn by subject.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 16 subjects were enrolled; 15 were randomized, and 14 subjects were treated and included in final data analysis. 1 subject was not randomized because the interactive voice response system did not work at the time of enrollment; 1 consent withdrawn by subject.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141

    Reporting group title
    BMS-986141 0.8 mg
    Reporting group description
    		 BMS-986141 0.8 mg QD for up to 28 days

    Reporting group title
    BMS-986141 4.8 mg
    Reporting group description
    		 BMS-986141 4.8 mg QD for up to 28 days

    Reporting group values
    		 Placebo BMS-986141 0.8 mg BMS-986141 4.8 mg Total
    Number of subjects
    		 2 5 7 14
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 1 3 3 7
        From 65-84 years
    		 1 2 4 7
        85 years and over
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.3 ± 9.2 64.8 ± 12.2 66.7 ± 7.6 -
    Sex: Female, Male
    Units: Subjects
        Female
    		 1 1 3 5
        Male
    		 1 4 4 9
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 0 2 1 3
        White
    		 2 3 5 10
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0
        Not Hispanic or Latino
    		 2 5 7 14
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141

    Reporting group title
    BMS-986141 0.8 mg
    Reporting group description
    		 BMS-986141 0.8 mg QD for up to 28 days

    Reporting group title
    BMS-986141 4.8 mg
    Reporting group description
    		 BMS-986141 4.8 mg QD for up to 28 days

    Primary: Number of subjects with composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28

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    End point title
    		 Number of subjects with composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 [1]
    End point description
    The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated subjects.
    End point type
    Primary
    End point timeframe
    28 Days
    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: Only summary statistics were planned for this end point.
    End point values
    		 Placebo BMS-986141 0.8 mg BMS-986141 4.8 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: subjects
    Notes
    [2] - Insufficient data available to perform analysis due to study termination
    [3] - Insufficient data available to perform analysis due to study termination
    [4] - Insufficient data available to perform analysis due to study termination
    No statistical analyses for this end point

    Primary: Percentage of subjects with composite of adjudicated major bleeding and adjudicated clinically relevant non-major (CRNM) bleeding during the treatment period

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    End point title
    		 Percentage of subjects with composite of adjudicated major bleeding and adjudicated clinically relevant non-major (CRNM) bleeding during the treatment period [5]
    End point description
    The proportion of subjects with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo.
    End point type
    Primary
    End point timeframe
    Up to 90 days
    Notes
    [5] - 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: Only summary statistics were planned for this end point.
    End point values
    		 Placebo BMS-986141 0.8 mg BMS-986141 4.8 mg
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [6] - Insufficient data available to perform analysis due to study termination
    [7] - Insufficient data available to perform analysis due to study termination
    [8] - Insufficient data available to perform analysis due to study termination
    No statistical analyses for this end point

    Secondary: Percentage of subjects with major adverse cardiovascular events (MACE)

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    End point title
    		 Percentage of subjects with major adverse cardiovascular events (MACE)
    End point description
    MACE was defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death. The percentage of treated subjects experiencing these events at Day 90 was to be reported by arm.
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Placebo BMS-986141 0.8 mg BMS-986141 4.8 mg
    Number of subjects analysed
    0 [9]
    0 [10]
    0 [11]
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [9] - Insufficient data available to perform analysis due to study termination
    [10] - Insufficient data available to perform analysis due to study termination
    [11] - Insufficient data available to perform analysis due to study termination
    No statistical analyses for this end point

    Secondary: Percentage of subjects with adjudicated symptomatic recurrent stroke (including fatal and non-fatal)

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    End point title
    		 Percentage of subjects with adjudicated symptomatic recurrent stroke (including fatal and non-fatal)
    End point description
    The percentage of subjects with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated subjects.
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 Placebo BMS-986141 0.8 mg BMS-986141 4.8 mg
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [12] - Insufficient data available to perform analysis due to study termination
    [13] - Insufficient data available to perform analysis due to study termination
    [14] - Insufficient data available to perform analysis due to study termination
    No statistical analyses for this end point

    Secondary: Percentage of subjects with composite of unrecognized brain infarction assessed by MRI at Day 28 and MACE at Day 90

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    End point title
    		 Percentage of subjects with composite of unrecognized brain infarction assessed by MRI at Day 28 and MACE at Day 90
    End point description
    The percentage of subjects with unrecognized brain infarction at Day 28 and MACE at Day 90 was to be reported by arm for all treated subjects.
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 Placebo BMS-986141 0.8 mg BMS-986141 4.8 mg
    Number of subjects analysed
    0 [15]
    0 [16]
    0 [17]
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [15] - Insufficient data available to perform analysis due to study termination
    [16] - Insufficient data available to perform analysis due to study termination
    [17] - Insufficient data available to perform analysis due to study termination
    No statistical analyses for this end point

    Secondary: Percentage of subjects composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death

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    End point title
    		 Percentage of subjects composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death
    End point description
    The percentage of treated subjects with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm.
    End point type
    Secondary
    End point timeframe
    Day 90
    End point values
    		 Placebo BMS-986141 0.8 mg BMS-986141 4.8 mg
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    Units: Percentage of subjects
        number (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [18] - Insufficient data available to perform analysis due to study termination
    [19] - Insufficient data available to perform analysis due to study termination
    [20] - Insufficient data available to perform analysis due to study termination
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141

    Reporting group title
    BMS-986141 0.8 mg
    Reporting group description
    		 BMS-986141 0.8 mg QD for up to 28 days

    Reporting group title
    BMS-986141 4.8 mg
    Reporting group description
    		 BMS-986141 4.8 mg QD for up to 28 days

    Serious adverse events
    		 Placebo BMS-986141 0.8 mg BMS-986141 4.8 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo BMS-986141 0.8 mg BMS-986141 4.8 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    4 / 5 (80.00%)
    3 / 7 (42.86%)
    Investigations
    Blood Potassium Increased
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Oedema Peripheral
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Vaginal Discharge
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Vulvovaginal Pruritis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 5 (40.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Micturation Urgency
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle Spasms
         subjects affected / exposed
    0 / 2 (0.00%)
    3 / 5 (60.00%)
    0 / 7 (0.00%)
         occurrences all number
    2
    3
    0
    Infections and infestations
    Tinea Pedis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
         occurrences all number
    0
    0
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2016
    Changed top dose to be studied from 16 mg QD to 8 mg QD. Initiation of the 8 mg dose group will only begin following DMC review of safety and laboratory data from the Day 28 study visit for at least 10% of total planned subjects. Changes were made to some exclusion criteria to minimize subject risk. Guidance around the use of CYP3A4 inhibitors and inducers has been further clarified. The statistical sections and sample size calculations have been updated to correspond to these changes. PK sampling windows were expanded; changed requirements for contraception to be the use of one highly effective method of contraception or one less effective method of contraception; added statement to Appendix 1 that local laws and regulations may require use of alternative and/or additional contraception methods; clarified genotyping testing; provided further clarifications to assist with study implementation; updated text per new BMS protocol model document template; corrected typographical errors.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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