A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Purpose
The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.
Conditions
- Acute Ischemic Stroke
- Transient Ischemic Attack (TIA)
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male and Female ≥40 years of age - Acute Ischemic Stroke or Transient Ischemic Attack - Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain area
Exclusion Criteria
- Predicted inability to swallow study medication - Any condition that, in the opinion of the Investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding - Use of thrombolytic therapy or mechanical thrombectomy for treatment of index stroke Other protocol defined inclusion/exclusion criteria could apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Placebo Comparator BMS-986177 Placebo |
Specified Dose on Specified Days |
|
Experimental Dose 1: BMS-986177 + Aspirin + Clopidogrel |
Specified Dose on Specified Days |
|
Experimental Dose 2: BMS-986177 + Aspirin + Clopidogrel |
Specified Dose on Specified Days |
|
Experimental Dose 3: BMS-986177 + Aspirin + Clopidogrel |
Specified Dose on Specified Days |
|
Experimental Dose 4: BMS-986177 + Aspirin + Clopidogrel |
Specified Dose on Specified Days |
|
Experimental Dose 5: BMS-986177 + Aspirin + Clopidogrel |
Specified Dose on Specified Days |
|
Experimental Dose 6: BMS-986177 + Aspirin + Clopidogrel |
Specified Dose on Specified Days |
|
Experimental Dose 7: BMS-986177 + Aspirin + Clopidogrel |
Specified Dose on Specified Days |
|
More Details
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb