This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke.
A prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF and with high risk factors.
- Aspirin Drug
Other Names: Aspirin at bedtime ARM 1: Kind: Experimental Label: Aspirin (ASA) Description: Aspirin 100 mg od (n~1000)
- Rivaroxaban (15 mg) Drug
Other Names: Xarelto Intervention Desc: Rivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following: Left atrial enlargement ≥ 5.5 cm, OR Left atrial spontaneous echo contrast OR Left atrial thrombus OR Frequent ectopic atrial activity (>1000/24 hours) on Holter ECG. ARM 1: Kind: Experimental Label: Rivaroxaban (15 mg) Description: Rivaroxaban 15 mg od (n ~ 1000)
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Time from randomization to the first occurrence of Stroke or systemic embolism||Approximately 4 years||No|
|Secondary||Time from randomization to the first occurrence of Myocardial Infarction (MI)||Approximately 4 years||No|
|Secondary||Time from randomization to time of vascular death||Approximately 4 years||No|