Study to Evaluate the Prevention of Stroke Recurrence with BMS-986177 in Patients Receiving Aspirin and Clopidogrel

A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Covert Brain Infarction in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225014

Enrollment

2350

Registered

2020-01-14

Start date

2020-01-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

New Ischemic Stroke or New Covert Brain Infarction

Interventions

investigational material(s) Generic name etc : INN of investigational material : - Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Administration for Invest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Participants >=40 years of age -Patients with acute ischemic stroke or transient ischemic attack -Patients with atherosclerotic plaques in the intracranial or carotid arteries

Exclusion criteria

Exclusion criteria: -Patients who are expected to have difficulty swallowing the investigational drug -Patients for whom anticoagulant therapy is contraindicated or who are considered to have an unacceptable risk of bleeding, as determined by the principal (or sub-investigator), -Patients undergoing thrombolytic therapy or mechanical thrombectomy for the treatment of the index event.

Design outcomes

Primary

Measure	Time frame
efficacy other The composite of new ischemic stroke during the treatment period and new asymptomatic cerebral infarction confirmed by MRI (FLAIR + DWI) on Day 90	—

Secondary

Measure	Time frame
-Event incidence rate based on BARC Type 3 and Type 5 bleeding -Event incidence rate based on criteria defined by BARC, ISTH, and PLATO -Incidence rate of the composite endpoint of new ischemic stroke during the treatment period and new asymptomatic cerebral infarction confirmed by MRI on Day 90 -Location, number, and volume of new FLAIR + DWI lesions -Event incidence rate of new non-fatal ischemic stroke, non-fatal MI, and all-cause mortality during the treatment period -NIHSS, Modified Rankin Score (mRS), and MoCA on Day 21, Day 90, and at the time of new stroke event occurrence -AEs, vital signs, physical examinations, ECGs, and clinical laboratory values -Estimated clearance (CL) and volume of distribution (Vd) -Change rate from baseline in aPTT and FXI coagulation activity during the treatment period	—

Measure

Time frame

-Event incidence rate based on BARC Type 3 and Type 5 bleeding -Event incidence rate based on criteria defined by BARC, ISTH, and PLATO -Incidence rate of the composite endpoint of new ischemic stroke during the treatment period and new asymptomatic cerebral infarction confirmed by MRI on Day 90 -Location, number, and volume of new FLAIR + DWI lesions -Event incidence rate of new non-fatal ischemic stroke, non-fatal MI, and all-cause mortality during the treatment period -NIHSS, Modified Rankin Score (mRS), and MoCA on Day 21, Day 90, and at the time of new stroke event occurrence -AEs, vital signs, physical examinations, ECGs, and clinical laboratory values -Estimated clearance (CL) and volume of distribution (Vd) -Change rate from baseline in aPTT and FXI coagulation activity during the treatment period

—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Contacts

Public ContactKahl Anja

Bristol-Myers Squibb

mg-jp-clinical_trial@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026