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

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671461
• Other study ID #: CV006-004
• Status: Completed
• Phase: Phase 2
• Start date: April 25, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: December 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• BMS-986141

• Aspirin

Other:
• Placebo

Locations

Country	Name	City	State
Japan	Local Institution	Fukuoka
Japan	Local Institution	Hidaka-shi	Saitama
Japan	Local Institution	Kobe-shi	Hyogo
Japan	Local Institution	Nagoya	Aichi
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sendai-shi	Miyagi
United States	Local Institution	Baltimore	Maryland
United States	Boston Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Local Institution	Chapel Hill	North Carolina
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	JFK Medical Center	Edison	New Jersey
United States	University Of Florida	Gainesville	Florida
United States	Advanced Neurology Specialists	Great Falls	Montana
United States	Guilford Medical Associates, Pa	Greensboro	North Carolina
United States	University Of Florida Hsc/Jacksonville	Jacksonville	Florida
United States	Presence Saint Joseph Medical Center	Joliet	Illinois
United States	St. Lukes Marion Bloch Neuroscience Institute	Kansas City	Missouri
United States	University Of Louisville	Louisville	Kentucky
United States	Local Institution	Memphis	Tennessee
United States	West Virginia University	Morgantown	West Virginia
United States	Local Institution	Newark	Delaware
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Local Institution	Omaha	Nebraska
United States	Florida Hospital	Orlando	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner University Medical Ctr	Phoenix	Arizona
United States	Oregon Health Science Univ	Portland	Oregon
United States	Providence Portland Med Ctr	Portland	Oregon
United States	Providence St Vincent Medical Center	Portland	Oregon
United States	Intercoastal Medical Group	Sarasota	Florida
United States	York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form