Rivaroxaban in Mechanical Valves: RMV Study

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

Details

• Lead Sponsor: Hospital Ana Nery
• Collaborator: Federal University of Bahia
• Treatments: Rivaroxaban

Criteria

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;