Rivaroxaban in Mechanical Valves: RMV Study (RMV)

March 9, 2018 updated by: Andre Duraes, MD, PhD, Hospital Ana Nery

Evaluation of Thromboembolic Events in Patients With Bileaflet Mechanical Valves in Mitral Position Before and After Rivaroxaban Use: RMV Study

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

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). Warfarin works by binding to vitamin K epoxide reductase to inhibit vitamin K-dependent coagulation factors II, VII, IX, and X. For all its extensive use, warfarin has many clinical shortcomings, including variable pharmacokinetic and pharmacodynamics properties, a narrow therapeutic index range, and numerous interactions with certain foods and drugs. All of these factors contribute to the need for frequent coagulation laboratory monitoring and dosage adjustments.

Even with the appropriate use of therapy, the incidence of thromboembolic events is still substantial: 1-4% per year. Furthermore, bleeding risk is significant, ranging from 2% to 9% per year. The VKA's narrow therapeutic index and they have a complex pharmacology, e.g. long pharmacologic inertia and the common interaction with other drugs. These features make the management of these drugs a challenge for physicians and their patients.

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. Most thromboembolic events among patients in the dabigatran group occurred in population A (patients who had started a study drug within 7 days after valve surgery), with fewer occurring in population B (patients who had undergone valve implantation more than 3 months before randomization). Besides, stroke, death and major bleeding occurred only in population A. In this study, rivaroxaban will be used in patients with mechanical valves and unstable INR in a before and after designed.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age from 18 to 64 years at entry;
  • Patients with mitral mechanical valve for at least 3 months postoperatively;
  • Brain computed tomography scan without hemorrhage or findings of acute cerebral infarction on the last 2 days of screening;
  • Exclusion of atrial thrombus or valve prosthesis thrombosis by transesophageal echocardiograph on the last 2 days of screening;
  • Written, informed consent;

Exclusion Criteria:

  • Previous hemorrhagic stroke;
  • Ischemic stroke in the last 6 months;
  • Renal impairment (creatinine clearance rates < 50 ml/min);
  • Active liver disease (any etiology);
  • Concomitant use of any antiplatelet (aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, etc);
  • Increased risk of bleeding (congenital or acquired);
  • Uncontrolled hypertension;
  • Gastrointestinal hemorrhage within the past year;
  • Anemia (hemoglobin level <10 g/dL) or thrombocytopenia (platelet count < 100 × 109/L);
  • Active infective endocarditis;
  • Pregnant or lactating women;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Ana Nery

Collaborators

Federal University of Bahia

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 5, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69327617.7.0000.5028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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