Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"

Completed · Phase 2 · Has a placebo group

Conditions studied: Thrombosis

In brief

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.

Key facts

Study ID

NCT02671461

Run by

Bristol-Myers Squibb

People needed

16

Starts

2016-04-25

Expected to finish

2017-03-31

Last updated by the study team

2018-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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