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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
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: 1. Left atrial enlargement ≥ 5.5 cm, OR 2. Left atrial spontaneous echo contrast OR 3. Left atrial thrombus OR 4. Frequent ectopic atrial activity (\>1000/24 hours) on Holter ECG.
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: 1. Left atrial enlargement ≥ 5.5 cm, OR 2. Left atrial spontaneous echo contrast OR 3. Left atrial thrombus OR 4. Frequent ectopic atrial activity (\>1000/24 hours) on Holter ECG.
Time from randomization to the first occurrence of Stroke or systemic embolism
Stroke (Ischemic, hemorrhagic or undetermined type)
Time frame: Approximately 4 years
Time from randomization to the first occurrence of Myocardial Infarction (MI)
Time frame: Approximately 4 years
Time from randomization to time of vascular death
Vascular death includes death due to stroke, myocardial infarction, heart failure or cardiogenic shock, sudden death or any other death due to cardiovascular causes. In addition, death due to hemorrhage will be included
Time frame: Approximately 4 years
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