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

Valvular Heart Disease Clinical Trial

Official title:
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

Clinical Trial Summary

RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02303795
Study type Interventional
Source Hospital do Coracao
Contact
Status Completed
Phase Phase 2
Start date August 2015
Completion date August 2020
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