Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"
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
1 other identifier
interventional
16
2 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2016
Shorter than P25 for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedStudy Start
First participant enrolled
April 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedResults Posted
Study results publicly available
June 12, 2018
CompletedDecember 14, 2018
December 1, 2018
11 months
January 29, 2016
March 30, 2018
December 12, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28
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.
28 Days
Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period
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.
Up to 90 days
Secondary Outcomes (4)
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
90 days
Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal)
Day 28
Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90
Day 90
Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death
Day 90
Study Arms (3)
BMS-986141 0.8mg
EXPERIMENTALBMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)
BMS-986141 4.8mg
EXPERIMENTALBMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets)
Placebo
PLACEBO COMPARATORPlacebo orally (tablets) and ASA 75 to 162 mg orally (tablets)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Banner University Medical Ctr
Phoenix, Arizona, 85006, United States
Hoag Memorial Hospital
Newport Beach, California, 92658, United States
Local Institution
Newark, Delaware, 19718, United States
University Of Florida
Gainesville, Florida, 32610, United States
University Of Florida Hsc/Jacksonville
Jacksonville, Florida, 32209, United States
Florida Hospital
Orlando, Florida, 32803, United States
Intercoastal Medical Group
Sarasota, Florida, 34239, United States
Presence Saint Joseph Medical Center
Joliet, Illinois, 64035, United States
University Of Louisville
Louisville, Kentucky, 40202, United States
Local Institution
Baltimore, Maryland, 21215, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
St. Lukes Marion Bloch Neuroscience Institute
Kansas City, Missouri, 64111, United States
Advanced Neurology Specialists
Great Falls, Montana, 59405, United States
Local Institution
Omaha, Nebraska, 68105, United States
JFK Medical Center
Edison, New Jersey, 08820-3947, United States
Local Institution
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Guilford Medical Associates, Pa
Greensboro, North Carolina, 27405, United States
Providence Portland Med Ctr
Portland, Oregon, 97225, United States
Providence St Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health Science Univ
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
York Hospital
York, Pennsylvania, 17403, United States
Medical University Of South Carolina
Charleston, South Carolina, 29425, United States
Local Institution
Memphis, Tennessee, 38103, United States
West Virginia University
Morgantown, West Virginia, 26505, United States
Local Institution
Nagoya, Aichi-ken, 4600001, Japan
Local Institution
Sapporo, Hokkaido, 0608570, Japan
Local Institution
Kobe, Hyōgo, 6500047, Japan
Local Institution
Sendai, Miyagi, 982-8523, Japan
Local Institution
Hidaka-shi, Saitama, 3501298, Japan
Local Institution
Fukuoka, 810-0001, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2016
First Posted
February 2, 2016
Study Start
April 25, 2016
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
December 14, 2018
Results First Posted
June 12, 2018
Record last verified: 2018-12