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

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.

Study Overview

• Status: Completed
• Conditions: Thrombosis
• Intervention / Treatment: Other: Placebo; Drug: Aspirin; Drug: BMS-986141

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 810-0001
    • Local Institution
  • Aichi
    • Nagoya, Aichi, Japan, 4600001
      • Local Institution
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 0608570
      • Local Institution
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 6500047
      • Local Institution
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 982-8523
      • Local Institution
  • Saitama
    • Hidaka-shi, Saitama, Japan, 3501298
      • Local Institution
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Ctr
  • California
    • Newport Beach, California, United States, 92658
      • Hoag Memorial Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Local Institution
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Jacksonville, Florida, United States, 32209
      • University Of Florida Hsc/Jacksonville
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Sarasota, Florida, United States, 34239
      • Intercoastal Medical Group
  • Illinois
    • Joliet, Illinois, United States, 64035
      • Presence Saint Joseph Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Local Institution
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Lukes Marion Bloch Neuroscience Institute
  • Montana
    • Great Falls, Montana, United States, 59405
      • Advanced Neurology Specialists
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Local Institution
  • New Jersey
    • Edison, New Jersey, United States, 08820-3947
      • JFK Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Local Institution
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Greensboro, North Carolina, United States, 27405
      • Guilford Medical Associates, Pa
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St Vincent Medical Center
    • Portland, Oregon, United States, 97225
      • Providence Portland Med Ctr
    • Portland, Oregon, United States, 97239
      • Oregon Health Science Univ
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • York, Pennsylvania, United States, 17403
      • York Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Local Institution
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986141 0.8mg; BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)	Drug: Aspirin; Drug: BMS-986141
Experimental: BMS-986141 4.8mg; BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets)	Drug: Aspirin; Drug: BMS-986141
Placebo Comparator: Placebo; Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets)	Other: Placebo; Drug: Aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)	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.	90 days
Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal)	The percentage of participants with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated participants.	Day 28
Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at 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.	Day 90
Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death	The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm.	Day 90

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2016
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): March 31, 2017

Study Registration Dates

• First Submitted: January 29, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): December 14, 2018
• Last Update Submitted That Met QC Criteria: December 12, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: CV006-004