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Rivaroxaban in Mechanical Valves: RMV Study

NCT02894307 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2018-03-13

No results posted yet for this study

Summary

Anticoagulant treatment reduces the incidence of death and cardioembolic events in patients with atrial fibrillation or prosthetic heart valve and the incidence of death and recurrences in patients with VTE. Warfarin and similar vitamin K antagonists (VKA) have been the standard therapy for patients with a metallic valve, or bioprosthesis with atrial fibrillation (AF). The Dabigatran versus Warfarin in Patients with Mechanical Heart Valves (RE-ALIGN) trial comparing dabigatran etexilate to warfarin was the only randomized controlled study in patient with mechanical valve prosthesis, but it was terminated prematurely because of an excess of thromboembolic and bleeding events among patients in the dabigatran group. To date, novel oral anticoagulants (NOACs) have shown to be not both safe and or effective for patients with mechanical valves.

Conditions

  • Prosthesis; Cardiac, Heart, Functional Disturbance as Result

Interventions

DRUG

Rivaroxaban

In patients with mechanical valves and unstable INR

Sponsors & Collaborators

  • Federal University of Bahia

    collaborator OTHER

  • Hospital Ana Nery

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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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 NCT02894307 on ClinicalTrials.gov