Rivaroxaban in Mechanical Valves: RMV Study

NCT02894307 | Unknown

• 1 other identifier: 69327617.7.0000.5028
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Mechanical prosthesis; Rivaroxaban

Interventions

Rivaroxaban DRUG

In patients with mechanical valves and unstable INR

Also known as: Xarelto 15 mg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Written, informed consent;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hospital Ana Nery: lead
• Federal University of Bahia: collaborator

Related Publications (2)

• 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.

  PMID: 26892845 RESULT

• 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.

  PMID: 30098707 DERIVED

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr Andre Duraes

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: September 9, 2016
• Last Updated: March 13, 2018

Record last verified: 2018-03