MedTrace Logo

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

NCT02832531 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-07-19

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, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with AF and unsuitable for VKA or without AF and with high risk factors.

Conditions

  • Rheumatic Heart Disease

Interventions

DRUG

Rivaroxaban (15 mg)

Rivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following: 1. Left atrial enlargement ≥ 5.5 cm, OR 2. Left atrial spontaneous echo contrast OR 3. Left atrial thrombus OR 4. Frequent ectopic atrial activity (\>1000/24 hours) on Holter ECG.

DRUG

Aspirin

Rivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following: 1. Left atrial enlargement ≥ 5.5 cm, OR 2. Left atrial spontaneous echo contrast OR 3. Left atrial thrombus OR 4. Frequent ectopic atrial activity (\>1000/24 hours) on Holter ECG.

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • Population Health Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-04-30
Completion
2022-08-31

More Related Trials

Entities

Drugs

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 NCT02832531 on ClinicalTrials.gov