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

NCT02832544 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4565

Last updated 2022-10-05

No results posted yet for this study

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.

Conditions

  • Rheumatic Heart Disease

Interventions

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)

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Stuart Connolly, MD · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-22
Primary Completion
2022-08-18
Completion
2022-08-18

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

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02832544 on ClinicalTrials.gov