Rheumatic Heart Disease Clinical Trial
Official title:
INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies
This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke. A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to VKA, with testing for superiority if non-inferiority is satisfied.
Non-Inferiority Trial of rivaroxaban versus VKAs: 4,500 patients Inclusion Criteria: 1. RVHD diagnosed by echocardiography at any time prior to enrollment 2. Age ≥18 3. Increased risk of stroke by any of the following 1. CHA2DS2-VASc score ≥ 2 OR 2. Moderate/Severe mitral stenosis with valve area ≤2.0 cm2 OR 3. Left atrial spontaneous echo contrast OR 4. Left atrial thrombus 4. Heart Rhythm a) AF or Flutter should be documented on baseline 12-lead ECG, or on a previous 12-lead ECG, Holter monitor, in-hospital ECG rhythm strip or Pacemaker or ICD electrogram. Treatment: Patients will be randomized either to receive rivaroxaban or any approved VKA. Treatment will be open-label. 1. Rivaroxaban Arm - Rivaroxaban 20 mg once daily - Rivaroxaban 15 mg once daily (for patients with an creatinine clearance ≥15 and <50 ml/min) 2. VKA Arm - Any VKA approved for use in the participating country - VKA titrated to achieve an INR of 2.0-3.0 ;
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