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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Thrombosis

Treatments: Drug: Aspirin; Other: Placebo; Drug: BMS-986141

Study type: Interventional

Funder types: Industry

Identifiers

NCT02671461

CV006-004

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 3 patient groups, including a placebo group

BMS-986141 0.8mg

Experimental group

Description:

BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)

Treatment:

Drug: Aspirin

Drug: BMS-986141

BMS-986141 4.8mg

Experimental group

Description:

BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets)

Treatment:

Drug: Aspirin

Drug: BMS-986141

Placebo

Placebo Comparator group

Description:

Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets)

Treatment:

Drug: Aspirin

Other: Placebo