NCT02387229

Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF

Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF (BRAIN-AF)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,238 (actual)
• Sponsor: Montreal Heart Institute · Academic / Other
• Sex: All
• Age: 30 Years – 62 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized, double-blinded clinical trial exploring the efficacy and safety of rivaroxaban as compared to standard of care in reducing stroke, transient ischemic attack (TIA) and neurocognitive decline, in subjects with non-valvular AF and with low risk of stroke.

Detailed description

Subjects who qualify will be approached and those consenting will be enrolled to undergo a baseline evaluation. Subjects without a clinical diagnosis of dementia and with a Mini Mental State Examination score (MMSE) score ≥ 25 will undergo neurocognitive assessment (MoCA), psychosocial and QoL assessment before randomization. Subjects will undergo regular visits (in-clinic, and/or by phone, or video conferencing) every 6 months during the treatment period. Subjects will take either rivaroxaban 15 mg or standard of care. An independent clinical event committee will classify all endpoint events. An independent Data Safety Monitoring Committee (DSMC) was established to monitor the progress of the study and assure the safety of subjects enrolled in the trial.

Conditions

• ATRIAL FIBRILLATION

Interventions

Type	Name	Description
DRUG	Rivaroxaban	15 mg
OTHER	standard of care

Timeline

• Start date: 2015-03-01
• Primary completion: 2024-05-18
• Completion: 2024-05-18
• First posted: 2015-03-12
• Last updated: 2025-06-15

Locations

41 sites across 1 country: Canada