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.
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Inclusion
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30-60 years old
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30+ sec. documented Non-valvular AF in past 12 months
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Low risk of stroke as defined by the absence of:
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CHF (NYHA 2+)
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Prior CVA/TIA
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HTN
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DM
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Exclusion
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Known dementia/depression past 1 year
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Hx internal bleeding/ulcer
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Surgery past 1 m. or planned
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Planned PVI or absence of recurrence of AF 3 months after PVI
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Cancer or Rad. Tx
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Creatinine clearance 30 mL/min or less
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Acute liver disease
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(ALT >3 times the upper limit of normal)
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Anemia/thrombocytopenia
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Pregnant/breastfeeding
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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