Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"

Completed

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • Aspirin Drug
    Other Names: Aspirin at bedtime
    ARM 1: Kind: Experimental
    Label: BMS-986141 (low dose)
    Description: BMS-986141 low dose orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)
    ARM 2: Kind: Experimental
    Label: BMS-986141 (medium dose)
    Description: BMS-986141 medium dose orally (tablets) and ASA 75 to 162 mg orally (tablets)
    ARM 3: Kind: Experimental
    Label: BMS-986141 (high dose)
    Description: BMS-986141 high dose orally (tablets) and ASA 75 to 162 mg orally (tablets)
    ARM 4: Kind: Experimental
    Label: Placebo
    Description: Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets)
  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets)
  • BMS-986141 Drug
    ARM 1: Kind: Experimental
    Label: BMS-986141 (low dose)
    Description: BMS-986141 low dose orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets)
    ARM 2: Kind: Experimental
    Label: BMS-986141 (medium dose)
    Description: BMS-986141 medium dose orally (tablets) and ASA 75 to 162 mg orally (tablets)
    ARM 3: Kind: Experimental
    Label: BMS-986141 (high dose)
    Description: BMS-986141 high dose orally (tablets) and ASA 75 to 162 mg orally (tablets)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 Up to 28 days No
Primary 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 Up to 90 days Yes
Secondary The incidence of major adverse cardiovascular events (MACE) defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death 90 days after initial dose of study No
Secondary The incidence of adjudicated symptomatic recurrent stroke (including fatal and non-fatal) 28 days after initial dose of study No
Secondary The incidence of the composite of unrecognized brain infarction assessed by MRI at Day 28 and MACE at Day 90 90 days after initial dose of study No
Secondary The incidence of the composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death 90 days after initial dose of study No

Sponsors