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

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

Recruiting Locations

University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama 35233
Contact:
Rajbeer Sangha, Site 0029

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information
please email
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.