Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in Atrial Fibrillation "BRAIN-AF"

Recruiting

Phase 3 Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Rivaroxaban Drug
    Intervention Desc: 15 mg
    ARM 1: Kind: Experimental
    Label: Rivaroxaban
    Description: Rivaroxaban 15 mg/ Acetylsalicylic acid Placebo tablets, orally, once daily, preferably at the same time of the day throughout the study.
  • Acetylsalicylic acid Drug
    Intervention Desc: 100 mg
    ARM 1: Kind: Experimental
    Label: Acetylsalicylic acid
    Description: Acetylsalicylic acid 100 mg/ Rivaroxaban Placebo tablets, orally, once daily, preferably at the same time of the day throughout the study.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite endpoint of stroke, TIA and neurocognitive decline Up to a maximum of 78 months No
Secondary Death (total and cardiovascular) Up to a maximum of 78 months No
Secondary Composite including stroke/transient ischemic attack (TIA) and systemic embolic events Up to a maximum of 78 months No
Secondary Neurocognitive decline Up to a maximum of 78 months No
Secondary New-onset of mild cognitive impairment (MCI) Up to a maximum of 78 months No
Secondary Hospitalization for cardiovascular (myocardial infarction, heart failure, AF, stroke or unstable angina) or bleeding event Up to a maximum of 78 months No

Sponsors