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

ArmDescriptionAssigned Intervention
Placebo Comparator
BMS-986177 Placebo 		Specified Dose on Specified Days
  • Other: Placebo
    Oral Administration
  • Drug: Clopidogrel
    Oral administration
  • Drug: Aspirin
    Oral administration
Experimental
Dose 1: BMS-986177 + Aspirin + Clopidogrel 		Specified Dose on Specified Days
  • Drug: BMS-986177
    Oral administration
  • Drug: Clopidogrel
    Oral administration
  • Drug: Aspirin
    Oral administration
Experimental
Dose 2: BMS-986177 + Aspirin + Clopidogrel 		Specified Dose on Specified Days
  • Drug: BMS-986177
    Oral administration
  • Drug: Clopidogrel
    Oral administration
  • Drug: Aspirin
    Oral administration
Experimental
Dose 3: BMS-986177 + Aspirin + Clopidogrel 		Specified Dose on Specified Days
  • Drug: BMS-986177
    Oral administration
  • Drug: Clopidogrel
    Oral administration
  • Drug: Aspirin
    Oral administration
Experimental
Dose 4: BMS-986177 + Aspirin + Clopidogrel 		Specified Dose on Specified Days
  • Drug: BMS-986177
    Oral administration
  • Drug: Clopidogrel
    Oral administration
  • Drug: Aspirin
    Oral administration
Experimental
Dose 5: BMS-986177 + Aspirin + Clopidogrel 		Specified Dose on Specified Days
  • Drug: BMS-986177
    Oral administration
  • Drug: Clopidogrel
    Oral administration
  • Drug: Aspirin
    Oral administration
Experimental
Dose 6: BMS-986177 + Aspirin + Clopidogrel 		Specified Dose on Specified Days
  • Drug: BMS-986177
    Oral administration
  • Drug: Clopidogrel
    Oral administration
  • Drug: Aspirin
    Oral administration
Experimental
Dose 7: BMS-986177 + Aspirin + Clopidogrel 		Specified Dose on Specified Days
  • Drug: BMS-986177
    Oral administration
  • Drug: Clopidogrel
    Oral administration
  • Drug: Aspirin
    Oral administration

More Details

Status
Completed
Sponsor
Bristol-Myers Squibb

Study Contact