NCT02894307|Unknown
Rivaroxaban in Mechanical Valves: RMV Study
RMV
Evaluation of Thromboembolic Events in Patients With Bileaflet Mechanical Valves in Mitral Position Before and After Rivaroxaban Use: RMV Study
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RMV
Evaluation of Thromboembolic Events in Patients With Bileaflet Mechanical Valves in Mitral Position Before and After Rivaroxaban Use: RMV Study
Sponsor study identifier
expanded_access
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0 countries
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Study Start
Not reported
Date not reportedPrimary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedAnticoagulant 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 5, 2016
Actual (reported)September 9, 2016
Actual (reported)In patients with mechanical valves and unstable INR
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Duraes AR, de Souza Roriz P, de Almeida Nunes B, Albuquerque FP, de Bulhoes FV, de Souza Fernandes AM, Aras R. Dabigatran Versus Warfarin After Bioprosthesis Valve Replacement for the Management of Atrial Fibrillation Postoperatively: DAWA Pilot Study. Drugs R D. 2016 Jun;16(2):149-54. doi: 10.1007/s40268-016-0124-1.
Duraes AR, Bitar YSL, Lima MLG, Santos CC, Schonhofen IS, Filho JAL, Roever L. Usefulness and Safety of Rivaroxaban in Patients Following Isolated Mitral Valve Replacement With a Mechanical Prosthesis. Am J Cardiol. 2018 Sep 15;122(6):1047-1050. doi: 10.1016/j.amjcard.2018.06.015. Epub 2018 Aug 8.
First Submitted
September 5, 2016
First Posted
September 9, 2016
Last Updated
March 13, 2018
Record last verified: 2018-03
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Source: ClinicalTrials.gov.
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