♥ Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation (BRAIN-AF)
Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder afflicting 0.4% of the general population. The prevalence of AF is increasing, even after adjusting for age. Growing evidence suggests that the rate of cognitive impairment and dementia is magnified in patients with AF, independently of clinical stroke. Importantly, the strongest association between AF and dementia has been observed in patients
Patients deemed at low risk of stroke (i.e., without: congestive heart failure, hypertension, age ›75 years, diabetes, and prior stroke or transient ischemic attack) constitute a large subset (20-25%) of the AF population for whom aspirin is generally recommended.
This is a prospective, multicenter, randomized, double-blinded clinical trial exploring the efficacy and safety of rivaroxaban as compared to acetylsalicylic acid in reducing stroke, transient ischemic attack (TIA) and neurocognitive decline, in subjects with non-valvular AF and with low risk of stroke.
Subjects who qualify will be approached and those consenting will be enrolled to undergo a baseline evaluation including the modified mini mental state test (3MS). 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.
During the follow-up period or double-blind treatment period (between a minimum of 3.5 and 6.5 years depending on the length of the recruitment), subjects will receive study medications as fixed doses. During the follow-up period, subjects will visit the clinic every 6 months up to a maximum of 78 months. Subjects will take either rivaroxaban 15 mg with matching acetylsalicylic acid – placebo or acetylsalicylic acid 100 mg with matching rivaroxaban-placebo orally, once daily, preferably at the same time of the day throughout the study.
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.
If you have Atrial Fibrillation with a low risk of stroke and is interested to participate in this research study or if you need more information regarding the study, please contact us at 403-235-4109 or e-mail us at hfnurse@arcnetwork.ca
