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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| ClinicalTrials.gov Identifier: NCT02671461 |
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Recruitment Status :
Completed
First Posted : February 2, 2016
Results First Posted : June 12, 2018
Last Update Posted : December 14, 2018
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Thrombosis | Drug: BMS-986141 Drug: Aspirin Other: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (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 |
| Actual Study Start Date : | April 25, 2016 |
| Actual Primary Completion Date : | March 31, 2017 |
| Actual Study Completion Date : | March 31, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: BMS-986141 0.8mg
BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)
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Drug: BMS-986141 Drug: Aspirin |
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Experimental: BMS-986141 4.8mg
BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets)
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Drug: BMS-986141 Drug: Aspirin |
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Placebo Comparator: Placebo
Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets)
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Drug: Aspirin Other: Placebo |
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 [ Time Frame: 28 Days ]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 [ Time Frame: Up to 90 days ]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) [ Time Frame: 90 days ]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) [ Time Frame: Day 28 ]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 [ Time Frame: 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 [ Time Frame: Day 90 ]The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671461
Locations
Show 33 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol Myers Squibb | Bristol-Myers Squibb |
Study Documents (Full-Text)
Documents provided by Bristol-Myers Squibb:
Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan [PDF] November 19, 2015
Study Protocol [PDF] July 7, 2016
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02671461 |
| Other Study ID Numbers: |
CV006-004 |
| First Posted: | February 2, 2016 Key Record Dates |
| Results First Posted: | June 12, 2018 |
| Last Update Posted: | December 14, 2018 |
| Last Verified: | December 2018 |
Additional relevant MeSH terms:
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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 |