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.
- 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
Other Names: Aspirin 81 mg 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.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Prevention
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|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|