Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"
- Registration Number
- NCT02671461
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine whether BMS-986141 is effective in reducing the recurrence of stroke in people who recently had a stroke, or a transient ischemic attack (known as a TIA or "mini stroke") and are receiving acetylsalicylic acid (also known as aspirin or ASA) to treat the stroke or TIA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- Male or female, age 18 or older
- Must have had a very recent stroke or transient ischemic attack ("mini stroke") that can be confirmed by the study doctor
- Able to be assigned to a study group no later than 48 hours after the stroke occurred
- Has an image of the brain that confirms that the stroke was not caused by hemorrhage or other reason that could explain symptoms
- A suspicion by the study doctor that the transient ischemic attack or stroke was caused by a blood clot that formed in the heart; examples of this include history of an abnormal heart rhythm known as atrial fibrillation or a ventricular aneurysm or defect of the heart.
- Any condition requiring treatment with an anticoagulant
- History of intracranial hemorrhage ("bleeding in the brain")
- Gastrointestinal ("stomach or intestinal") bleeding in the last 3 months that required treatment
- Planned or anticipated invasive surgery or procedure during the study
- Unable to tolerate MRI procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Aspirin Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets) Placebo Placebo Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets) BMS-986141 4.8mg Aspirin BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets) BMS-986141 0.8mg Aspirin BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets) BMS-986141 0.8mg BMS-986141 BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets) BMS-986141 4.8mg BMS-986141 BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets)
- Primary Outcome Measures
Name Time Method Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28 28 Days The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants.
Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period Up to 90 days The percentage of participants with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Major Adverse Cardiovascular Events (MACE) 90 days MACE was defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death. The percentage of treated participants experiencing these events at Day 90 was to be reported by arm.
Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal) Day 28 The percentage of participants with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated participants.
Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90 Day 90 The percentage of participants with unrecognized brain infarction at Day 28 and MACE at Day 90 was to be reported by arm for all treated participants.
Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death Day 90 The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm.
Trial Locations
- Locations (23)
York Hospital
🇺🇸York, Pennsylvania, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Of Florida Hsc/Jacksonville
🇺🇸Jacksonville, Florida, United States
Local Institution
🇯🇵Fukuoka, Japan
Hoag Memorial Hospital
🇺🇸Newport Beach, California, United States
Intercoastal Medical Group
🇺🇸Sarasota, Florida, United States
Guilford Medical Associates, Pa
🇺🇸Greensboro, North Carolina, United States
Banner University Medical Ctr
🇺🇸Phoenix, Arizona, United States
Providence St Vincent Medical Center
🇺🇸Portland, Oregon, United States
Oregon Health Science Univ
🇺🇸Portland, Oregon, United States
Presence Saint Joseph Medical Center
🇺🇸Joliet, Illinois, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
JFK Medical Center
🇺🇸Edison, New Jersey, United States
Advanced Neurology Specialists
🇺🇸Great Falls, Montana, United States
Providence Portland Med Ctr
🇺🇸Portland, Oregon, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University Of Florida
🇺🇸Gainesville, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Medical University Of South Carolina
🇺🇸Charleston, South Carolina, United States
St. Lukes Marion Bloch Neuroscience Institute
🇺🇸Kansas City, Missouri, United States
University Of Louisville
🇺🇸Louisville, Kentucky, United States