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 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:

  1. Age ≥ 18
  2. AIS with persistent signs/sxs, or brain lesion documented by CT or MRI; & NIHSS7
  3. (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
  4. Randomization within 48 hours after sxs onset
  5. Ability to tolerate ASA (75 to 162 mg/day)