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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02671461
First received: January 29, 2016
Last updated: February 16, 2017
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Thrombosis
Drug: BMS-986141
Drug: Aspirin
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The primary efficacy endpoint of the study is measured by incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 [ Time Frame: Up to 28 days ]
  • The primary safety endpoint is incidence of a composite of adjudicated major bleeding and adjudicated clinically relevant non-major (CRNM) bleeding during the treatment period [ Time Frame: Up to 90 days ]

Secondary Outcome Measures:
  • The incidence of major adverse cardiovascular events (MACE) defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death [ Time Frame: 90 days after initial dose of study ]
  • The incidence of adjudicated symptomatic recurrent stroke (including fatal and non-fatal) [ Time Frame: 28 days after initial dose of study ]
  • The incidence of the composite of unrecognized brain infarction assessed by MRI at Day 28 and MACE at Day 90 [ Time Frame: 90 days after initial dose of study ]
  • The incidence of the composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death [ Time Frame: 90 days after initial dose of study ]

Estimated Enrollment: 1312
Study Start Date: April 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-986141 (low dose)
BMS-986141 low dose orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)
Drug: BMS-986141 Drug: Aspirin
Experimental: BMS-986141 (medium dose)
BMS-986141 medium dose orally (tablets) and ASA 75 to 162 mg orally (tablets)
Drug: BMS-986141 Drug: Aspirin
Experimental: BMS-986141 (high dose)
BMS-986141 high dose orally (tablets) and ASA 75 to 162 mg orally (tablets)
Drug: BMS-986141 Drug: Aspirin
Placebo Comparator: Placebo
Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets)
Drug: Aspirin Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02671461

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 187 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02671461     History of Changes
Other Study ID Numbers: CV006-004 
Study First Received: January 29, 2016
Last Updated: February 16, 2017

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on February 20, 2017