Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 6396
Summary
- Conditions
- Atrial Fibrillation
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 30 years and 62 years
- Gender
- Both males and females
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 asses...
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.
Tracking Information
- NCT #
- NCT02387229
- Collaborators
- Canadian Stroke Prevention Intervention Network
- The Montreal Health Innovations Coordinating Center (MHICC)
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Montreal Heart Institute Foundation
- Investigators
- Principal Investigator: Lena Rivard, MD Montreal Heart Institute Study Director: Andreas Orfanos, MD Montreal health Innovations Coordinating Centre
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