NCT02303795

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,005 (actual)
• Sponsor: Hospital do Coracao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Valvular Heart Disease

Interventions

Type	Name	Description
DRUG	Rivaroxaban	Patients assigned to rivaroxaban will receive oral rivaroxaban, 20 mg od. Patients with a calculated creatinine clearance of 30 to 49 mL/min per 1.73 m2 received a reduced dose of rivaroxaban of 15 mg od.
DRUG	Warfarin	Patients will take the warfarin once daily (q.d.). The individual doses will be titrated as needed to maintain a target INR of 2.0-3.0. Patients with 65 \> years old, should take warfarin (2,5mg/day) and all others patients should take 5mg/day.

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2014-12-01
• Last updated: 2022-04-12

Locations

1 site across 1 country: Brazil