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

Rheumatic Heart Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Heart Diseases
• Rheumatic Diseases
• Rheumatic Heart Disease

• NCT number: NCT02832544
• Study type: Interventional
• Source: Population Health Research Institute
• Status: Completed
• Phase: Phase 3
• Start date: August 22, 2016
• Completion date: August 18, 2022