BRAIN AF

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

Objective

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.

  1. Inclusion

    • 30-60 years old

    • 30+ sec. documented Non-valvular AF in past 12 months

    • Low risk of stroke as defined by the absence of:

    • CHF (NYHA 2+)

    • Prior CVA/TIA

    • HTN

    • DM

  2. Exclusion

    • Known dementia/depression past 1 year

    • Hx internal bleeding/ulcer

    • Surgery past 1 m. or planned

    • Planned PVI or absence of recurrence of AF 3 months after PVI

    • Cancer or Rad. Tx

    • Creatinine clearance 30 mL/min or less

    • Acute liver disease

    • (ALT >3 times the upper limit of normal)

    • Anemia/thrombocytopenia

    • Pregnant/breastfeeding

Not Enrolling

Additional Info

Ethics ID: REB16-0312

ClinicalTrials.gov ID: NCT02387229

 

Sponsor: Montreal Heart Institute

 

PI: Dr. Stephen Wilton

Phone: 403 210 6701

Email: sbwilton@ucalgary.ca

 

Admin: Jennifer McKeage

Phone: 403 210 6047

Email: jmckeage@ucalgary.ca

Updated Sept 19,2023