NCT02283294

Apixaban for Early Prevention of Recurrent Embolic Stroke and Hemorrhagic Transformation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Transient Ischemic Attack
• Stroke
• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Apixaban
DRUG	Warfarin

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2014-11-05
• Last updated: 2021-11-30
• Results posted: 2021-11-30

Locations

5 sites across 1 country: United States