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

NCT02303795 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1005

Last updated 2022-04-12

No results posted yet for this study

Summary

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

Conditions

  • Valvular Heart Disease

Interventions

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.

Sponsors & Collaborators

  • Hospital do Coracao

    lead OTHER

Principal Investigators

  • Otavio Berwanger, MD, PhD · Hospital do Coracao

  • Ricardo Pavanello, MD, PhD · Hospital do Coracao

  • Helio P Guimarães, MD, PhD · Hospital do Coracao

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02303795 on ClinicalTrials.gov