Thrombosis
Conditions
Interventions
investigational material(s)
Generic name etc : BMS-986141
INN of investigational material :
Therapeutic category code : 339 Other agents relating to blood and body fluides
Dosage and Administration f
Sponsors
Bristol-Myers Squibb K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint of the study is measured by incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ] •The primary safety endpoint is incidence of a composite of adjudicated major bleeding and adjudicated clinically relevant non-major (CRNM) bleeding during the treatment period [ Time Frame: Up to 90 days ] [ Designated as safety issue: Yes ] | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of major adverse cardiovascular events (MACE) defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death [ Time Frame: 90 days after initial dose of study ] [ Designated as safety issue: No ] The incidence of adjudicated symptomatic recurrent stroke (including fatal and non-fatal) [ Time Frame: 28 days after initial dose of study ] [ Designated as safety issue: No ] The incidence of the composite of unrecognized brain infarction assessed by MRI at Day 28 and MACE at Day 90 [ Time Frame: 90 days after initial dose of study ] [ Designated as safety issue: No ] The incidence of the composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death [ Time Frame: 90 days after initial dose of study ] [ Designated as safety issue: No ] | — |
Outcome results
None listed