A Phase 2 Study of an Investigational Drug for the Prevention of Recurrent Brain Infarction
Sponsor: Bristol-Myers Squibb
Principal Investigator: Jose Romero MD
Sub-investigators: Thanh Nguyen MD, Hugo Aparicio MD, Anna Cervantes-Arslanian MD, Melissa Mercado MD, Courtney Takahashi MD, Ayshe Ana Beesen MD
Summary: 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. To determine the dose-response relationship of BMS-986141 on the recurrence of brain infarction at 28 days as assessed by a composite of symptomatic ischemic stroke and unrecognized brain infarction as assessed by MRI in subjects with ischemic stroke or TIA treated with ASA.
Inclusion Criteria:
- Age ≥ 18
- AIS with persistent signs/sxs, or brain lesion documented by CT or MRI; & NIHSS7
- (OR) High-risk TIA: Neurological deficit attributed to focal brain ischemia by history or examination with complete resolution of the deficit, and one of the following: a) ABCD2≥4 OR motor/speech sxs; b) Symptomatic intracranial arterial occlusive disease documented by TCD, US or vascular imaging with ≥50% narrowing in diameter of a vessel that could account for the clinical presentation; c) Internal carotid arterial occlusive disease with ≥50% narrowing in diameter of a vessel that is presumed to be atherosclerotic and could account for the clinical presentation; d) Stenosis in the vertebral circulation that is presumed to be atherosclerotic and could account for the clinical presentation
- Randomization within 48 hours after sxs onset
- Ability to tolerate ASA (75 to 162 mg/day)