Share on facebook Share on Twitter Share on Google Plus Share This
Back to Results

PARFAIT


Title A Phase 2, Placebo Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of BMS-986141 For the Prevention of Recurrent Brain Infarction in Subjects receiving Acetylsalicylic Acid (ASA) following Acute Ischemic Stroke or Transient Ischemic Attack
Therapeutic Area Stroke, Transient Ischemic Attack
Principal Investigator David Thaler, MD, PhD
Min Age 18 Years
Gender Both
Contact Haley Huggins
617-636-7606
More Information https://clinicaltrials.gov/ct2/show/study/NCT02671461

Overview

The purpose of this study is to determine if the study drug, BMS-986141, is safe and prevents a future stroke when given daily to subjects who have experienced acute ischemic stroke or transient ischemic attack (TIA) and are also taking acetylsalicylic acid (also known as aspirin or ASA).

Study Details

Inclusion Criteria

  • Acute ischemis stroke or high-risk TIA
  • Enrolled within 48 hours after onset of symptoms
  • Able to tolerate ASA at a dose from 75 to 162 mg/day

Exclusion Criteria

  • Any history of atrial fibrillation (Afib)
  • Any condition requiring ongoing treatment with an anticoagulant
  • Planned or anticipated invasive surgery or procedure during study duration

Study Requirements

Subjects will undergo 90 days of treatment with BMS-986141 and Aspirin followed by a 120 day follow-up. Subjects will undergo assessments at Day 1, Day of Discharge, Day 10, Day 28, Day 56, Day 90 and Day 120. Subject will undergo blood draws 5 times during Day 1 and twice on Day 28. Additional laboratory tests will take place on Day 1, Day of Discharge, Day 28, Day 56 and Day 90. The total blood volume collected during the whole study will be approximately 230 ml (~15.5 tablespoons). Subject will receive a study-specific MRI on Day 1 and Day 28.

Number of research visits: 8 visits

Length of participation: 120 Days

Assessments: Physical exam, vital signs, MRI, ECG, platelet aggregation, PK sampling, hematology, urinalysis, clinical chemistry