Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis

• Status: Terminated
• Trial end date: 2020-04-26
• Target enrollment: 0
• Participant gender: All

Summary

Mechanical heart valves (MHV) demand lifelong anticoagulation with vitamin K antagonists (VKA) due to the high thrombogenicity of the prosthesis. Rivaroxaban has previously been tested in experimental and animal models with encouraging results. The investigators recently sent for publication an experiment with 7 patients who used rivaroxaban in metallic prosthesis with encouraging results. In this way it was decided to do a randomized non-inferiority clinical trial comparing rivaroxaban with warfarin in patients with metallic prosthesis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Geral Roberto Santos
• Treatments: Rivaroxaban; Vitamin K; Warfarin

Criteria

Inclusion Criteria:

• Mechanical prosthetic valve replacement after at least 3 months postoperative

Exclusion Criteria:

• Previous hemorrhagic stroke

• Ischemic stroke in the last 3 months

• Severe renal impairment (CrCl rates < 30 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 SAH

• Gastrointestinal hemorrhage within the past year

• Anemia (Hb level < 10 g/dl) or thrombocytopenia (platelet count < 100 × 109/l)

• Active infective endocarditis

• Pregnant or lactating women