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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"

Primary Purpose

Thrombosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986141
Aspirin
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banner University Medical Ctr
  • Hoag Memorial Hospital
  • Local Institution
  • University Of Florida
  • University Of Florida Hsc/Jacksonville
  • Florida Hospital
  • Intercoastal Medical Group
  • Presence Saint Joseph Medical Center
  • University Of Louisville
  • Local Institution
  • Tufts Medical Center
  • Boston Medical Center
  • St. Lukes Marion Bloch Neuroscience Institute
  • Advanced Neurology Specialists
  • Local Institution
  • JFK Medical Center
  • Local Institution
  • Duke University Medical Center
  • Guilford Medical Associates, Pa
  • Providence Portland Med Ctr
  • Providence St Vincent Medical Center
  • Oregon Health Science Univ
  • Hospital of the University of Pennsylvania
  • York Hospital
  • Medical University Of South Carolina
  • Local Institution
  • West Virginia University
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BMS-986141 0.8mg

BMS-986141 4.8mg

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 29, 2016
Last Updated
December 12, 2018
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02671461
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 25, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986141 0.8mg
Arm Type
Experimental
Arm Description
BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)
Arm Title
BMS-986141 4.8mg
Arm Type
Experimental
Arm Description
BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets)
Intervention Type
Drug
Intervention Name(s)
BMS-986141
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28
Description
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.
Time Frame
28 Days
Title
Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period
Description
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.
Time Frame
Up to 90 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
Description
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.
Time Frame
90 days
Title
Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal)
Description
The percentage of participants with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated participants.
Time Frame
Day 28
Title
Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90
Description
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.
Time Frame
Day 90
Title
Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death
Description
The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm.
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Banner University Medical Ctr
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Hoag Memorial Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Local Institution
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
University Of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University Of Florida Hsc/Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Intercoastal Medical Group
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Presence Saint Joseph Medical Center
City
Joliet
State/Province
Illinois
ZIP/Postal Code
64035
Country
United States
Facility Name
University Of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Local Institution
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
St. Lukes Marion Bloch Neuroscience Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Advanced Neurology Specialists
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Local Institution
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
JFK Medical Center
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820-3947
Country
United States
Facility Name
Local Institution
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Guilford Medical Associates, Pa
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Providence Portland Med Ctr
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Providence St Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Oregon Health Science Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Medical University Of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Local Institution
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4600001
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608570
Country
Japan
Facility Name
Local Institution
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Local Institution
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
982-8523
Country
Japan
Facility Name
Local Institution
City
Hidaka-shi
State/Province
Saitama
ZIP/Postal Code
3501298
Country
Japan
Facility Name
Local Institution
City
Fukuoka
ZIP/Postal Code
810-0001
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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