Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or Mini Strokes

Study Overview
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Brief Summary
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The purpose of this study is to determine whether BMS-986141 is effective in reducing the recurrence of stroke in people who recently had a stroke, or a transient ischemic attack (known as a TIA or mini stroke) and are receiving acetylsalicylic acid (also known as aspirin or ASA) to treat the stroke or TIA.

Official Title
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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

Conditions
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Thrombosis

Intervention / Treatment
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* Drug: BMS-986141
* Drug: Aspirin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Male or female, age 18 or older Must have had a very recent stroke or transient ischemic attack (mini stroke) that can be confirmed by the study doctor Able to be assigned to a study group no later than 48 hours after the stroke occurred Has an image of the brain that confirms that the stroke was not caused by hemorrhage or other reason that could explain symptoms Exclusion Criteria: A suspicion by the study doctor that the transient ischemic attack or stroke was caused by a blood clot that formed in the heart; examples of this include history of an abnormal heart rhythm known as atrial fibrillation or a ventricular aneurysm or defect of the heart. Any condition requiring treatment with an anticoagulant History of intracranial hemorrhage (bleeding in the brain) Gastrointestinal (stomach or intestinal) bleeding in the last 3 months that required treatment Planned or anticipated invasive surgery or procedure during the study Unable to tolerate MRI procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-986141 0.8mg<br>BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets) | Drug: BMS-986141<br> <br> Drug: Aspirin<br> <br> |
| Experimental: BMS-986141 4.8mg<br>BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets) | Drug: BMS-986141<br> <br> Drug: Aspirin<br> <br> |
| Placebo Comparator: Placebo<br>Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets) | Drug: Aspirin<br> <br> Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28 | 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 participants. | 28 Days | 
| Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period | The percentage of participants 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. | Up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | MACE was defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death. The percentage of treated participants experiencing these events at Day 90 was to be reported by arm. | 90 days | 
| Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal) | The percentage of participants with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated participants. | Day 28 | 
| Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90 | The percentage of participants with unrecognized brain infarction at Day 28 and MACE at Day 90 was to be reported by arm for all treated participants. | Day 90 | 
| Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death | The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm. | Day 90 |