Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"
NCT ID: NCT02671461
Last Updated: 2018-12-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2016-04-25
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMS-986141 0.8mg
BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)
BMS-986141
Aspirin
BMS-986141 4.8mg
BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets)
BMS-986141
Aspirin
Placebo
Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets)
Aspirin
Placebo
Interventions
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BMS-986141
Aspirin
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Banner University Medical Ctr
Phoenix, Arizona, United States
Hoag Memorial Hospital
Newport Beach, California, United States
Local Institution
Newark, Delaware, United States
University Of Florida
Gainesville, Florida, United States
University Of Florida Hsc/Jacksonville
Jacksonville, Florida, United States
Florida Hospital
Orlando, Florida, United States
Intercoastal Medical Group
Sarasota, Florida, United States
Presence Saint Joseph Medical Center
Joliet, Illinois, United States
University Of Louisville
Louisville, Kentucky, United States
Local Institution
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
St. Lukes Marion Bloch Neuroscience Institute
Kansas City, Missouri, United States
Advanced Neurology Specialists
Great Falls, Montana, United States
Local Institution
Omaha, Nebraska, United States
JFK Medical Center
Edison, New Jersey, United States
Local Institution
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Guilford Medical Associates, Pa
Greensboro, North Carolina, United States
Providence Portland Med Ctr
Portland, Oregon, United States
Providence St Vincent Medical Center
Portland, Oregon, United States
Oregon Health Science Univ
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Local Institution
Memphis, Tennessee, United States
West Virginia University
Morgantown, West Virginia, United States
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Kobe, Hyōgo, Japan
Local Institution
Sendai, Miyagi, Japan
Local Institution
Hidaka-shi, Saitama, Japan
Local Institution
Fukuoka, , Japan
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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CV006-004
Identifier Type: -
Identifier Source: org_study_id