Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation "AREST"

Recruiting

Phase 3 Results N/A

Trial Description

The purpose of this study is to evaluate if Apixaban will decrease the complication of having another stroke for people who have atrial fibrillation if initiated earlier than standard of care.

Detailed Description

This is an Open label, randomized, active control, parallel-group pilot trial to examine the effect of initiation of APIXABAN at days 0-3 (TIA), days 3-5 (small stroke) and days 7-9 (medium stroke) to decrease fatal and/or recurrent stroke/TIA in 120 subjects who have suffered a recent( 0 to 48 hours from symptoms) TIA, or small to medium ischemic stroke compared to standard of care warfarin treatment regimen. Subjects will be randomly assigned in a 1:1 ratio to one of two treatment arms (apixaban or warfarin). Subjects will be followed for a total of 180 days during from screening through monthly follow-up visits.

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    ARM 1: Kind: Experimental
    Label: Warfarin
    Description: standard of care warfarin starting at day 7┬▒5 (TIA) or day 14 ┬▒5 (small to medium ischemic stroke).
  • Apixaban Drug
    Other Names: BMS-562247
    ARM 1: Kind: Experimental
    Label: Apixaban
    Description: Apixaban twice a day for 180 days with drug initiation day 0-3 (TIA), day 3-5(small stroke) or day 7- 9 (medium stroke) respectively

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite endpoint of fatal stroke, recurrent ischemic stroke, or hemorrhagic stroke 180 days No
Secondary Any intracranial bleeds assessed by MRI/CT scan at day 14 and EOS or at outcome event 180 days Yes
Secondary Any major bleeds 180 days Yes

Sponsors