Clinical trial NCT02671461: Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28
timeFrame: 28 Days
measure: Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period
timeFrame: Up to 90 days
Secondary outcomes:
measure: Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
timeFrame: 90 days
measure: Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal)
timeFrame: Day 28
measure: Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90
timeFrame: Day 90
measure: Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death
timeFrame: Day 90
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Ctr
state: Arizona
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Newark
country: United States
facility: Local Institution
state: Delaware
city: Gainesville
country: United States
facility: University Of Florida
state: Florida
city: Jacksonville
country: United States
facility: University Of Florida Hsc/Jacksonville
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Sarasota
country: United States
facility: Intercoastal Medical Group
state: Florida
city: Joliet
country: United States
facility: Presence Saint Joseph Medical Center
state: Illinois
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: St. Lukes Marion Bloch Neuroscience Institute
state: Missouri
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Omaha
country: United States
facility: Local Institution
state: Nebraska
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
city: Chapel Hill
country: United States
facility: Local Institution
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Guilford Medical Associates, Pa
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Med Ctr
state: Oregon
city: Portland
country: United States
facility: Providence St Vincent Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health Science Univ
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Local Institution
state: Tennessee
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Sendai-shi
country: Japan
facility: Local Institution
state: Miyagi
city: Hidaka-shi
country: Japan
facility: Local Institution
state: Saitama
city: Fukuoka
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: