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

Launched by HOSPITAL DO CORACAO · Nov 25, 2014

Keywords

ClinConnect Summary

A Phase 2, Randomized, Open label, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Rivaroxaban compared with vitamin K antagonism in Patients with Atrial Fibrillation with Bioprosthetic Mitral valves - RIVER. Main analysis for the primary endpoint are based on the Restricted Mean Survival Time (RMST) method.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female patients aged \>18 years at time of inclusion
• • 2. Patients with Persistent or paroxysmal Atrial Fibrillation or flutter with bioprosthetic mitral valves.
• • The patient must be able to give informed consent
• 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.