NCT02832544

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,565 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Rheumatic Heart Disease

Interventions

Type	Name	Description
DRUG	Rivaroxaban (20 mg)	Rivaroxaban is non-inferior to VKAs for the prevention of stroke or systemic embolism in patients with AF/flutter and RVHD and potentially superior to VKAs.
DRUG	Vitamin K antagonists (VKA)

Timeline

• Start date: 2016-08-22
• Primary completion: 2022-08-18
• Completion: 2022-08-18
• First posted: 2016-07-14
• Last updated: 2022-10-05

Locations

139 sites across 25 countries: Botswana, Brazil, Cameroon, China, Egypt, Ethiopia, India, Kazakhstan, Kenya, Kyrgyzstan, Malawi, Mexico, Mozambique, Nepal, Nigeria, Pakistan, Paraguay, Philippines, Rwanda, South Africa, Sudan, Tanzania, Uganda, Zambia, Zimbabwe