Phase 2
N=15
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
Bottom Line
View on ClinicalTrials.gov: NCT02671461 ↗Enrolled (actual)
15
Serious AEs
6.7%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-986141 (Drug); Aspirin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28 |
— | — |
| PRIMARY Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period |
— | — |
| SECONDARY Percentage of Participants With Major Adverse Cardiovascular Events (MACE) |
— | — |
| SECONDARY Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal) |
— | — |
| SECONDARY Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90 |
— | — |
| SECONDARY Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT02671461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.