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)

简要总结

主要结局

次要结局

• Percent of Participants With Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90(From randomization to up to 90 days after randomization)
• Composite of Percent of Participants With New Ischemic Stroke, MI and All Cause Death(From randomization to up to 90 days after randomization)
• Modified Rankin Scale (mRS)(At baseline, on Days 21 and 90, and at the time of a new stroke event)
• Number of Participants With Clinically Significant Vital Sign Abnormalities(From first dose to up to 90 days after first dose)
• Number of Participants With Bleeding Based on ISTH-Defined Criteria(From first dose to up to 107 days after first dose)
• Percent of Participants With Major Bleeding According to BARC Type 3 and 5(From first dose to up to 107 days after first dose)
• Number of Participants With Bleeding Based on BARC Types 1-5(From first dose to up to 107 days after first dose)
• Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(From first dose to up to 90 days after first dose)
• Pharmacokinetic Parameter - Estimated Clearance (CL)(From first dose to up to 90 days after first dose)
• Number of Participants With Bleeding Based on PLATO-Defined Criteria(From first dose to up to 107 days after first dose)
• Montreal Cognitive Assessment (MoCA)(At baseline, on Days 21 and 90, and at the time of a new stroke event)
• Percent Change From Baseline in Factor XI Clotting Activity(Baseline and day 90)
• Digit Symbol Substitution Test (DSST)(At baseline, on Days 21 and 90, and at the time of a new stroke event)
• Number of Participants With Adverse Events (AEs)(From first dose to 2 days after last dose of study therapy (up to approximately 107 days))
• National Institutes of Health Stroke Scale (NIHSS)(At baseline, on Days 21 and 90, and at the time of a new stroke event)
• Number of Participants With Clinically Significant Physical Examination Abnormalities(From first dose to up to 90 days after first dose)
• Number of Participants With Clinically Significant Laboratory Abnormalities - Liver(From first dose to up to approximately 38 months)
• Percent Change From Baseline in aPTT Activity(Baseline and day 90)
• Volume of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI(At day 90)
• Pharmacokinetic Parameter - Volume of the Central Compartment (VC)(From first dose to up to 90 days after first dose)
• Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI(At day 90)