RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial -RIVER Trial

Exclusion Criteria

• •1. Cardiovascular-related conditions as known presence of cardiac thrombus or tumor
• •* Active endocarditis
• •* Uncontrolled hypertension
• •2. Hemorrhage risk-related criteria
• •* Active internal bleeding
• •* History of, or condition associated with, increased bleeding risk
• •3. Concomitant conditions and therapies
• •* History of previous thromboembolism with high risk of bleeding:
• •* Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months
• •* Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
• •* Acute MI within the last 14 days prior to randomization
• •* Treatment with: Chronic aspirin therapy \> 100 mg daily or dual antiplatelet therapy; Intravenous antiplatelets; Fibrinolytics; Anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; Systemic treatment with a strong inhibitor of cytochrome P450 3A4, such as ketoconazole or protease inhibitors; Treatment with a strong inducer of cytochrome P450 3A4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
• •* Anemia
• •* Pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
• •* Calculated creatinine clearance bellow 30 mL/min
• •* Known significant liver disease or alanine aminotransferase N3× the upper limit of normal
• •* Previous participation in this study.