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INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Superiority | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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

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

NCT02832531•Population Health Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•1. AF or Flutter and unsuitable for VKA therapy. (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). OR
•2. In the absence of AF or Flutter, patients would be eligible in the presence of any one of the following:
+5 more criteria

Exclusion Criteria

•1. Refusal to give informed consent
•2. Actively involved in any study that would compromise the protocol of INVICTUS Trial
•3. Severe co-morbid condition with life expectancy \< 1 year
•4. Other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.
•5. Likely to have valve replacement surgery within 6 months
•6. Mechanical valve prosthesis or other condition requiring treatment with VKAs. Patients with deep vein thrombosis or recent pulmonary embolism can be enrolled where both VKAs and rivaroxaban are approved.
•7. Contraindication to the study medication of the trial
•* Allergy to rivaroxaban
•* Allergy to VKAs ( non-inferiority trial)
•* Allergy to aspirin ( superiority trial)
+9 more criteria

Key Dates

Start Date

January 1, 2022

Primary Completion Date

April 1, 2022

Completion Date

August 1, 2022

Last Updated

July 19, 2022

Conditions

Rheumatic Heart Disease

Interventions

Rivaroxaban (15 mg)

DRUG

Aspirin

DRUG

Case Management and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease

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UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Case Management and Peer Support Groups for Prophylaxis Adherence in Rheumatic Heart Disease

Dapagliflozin Effect on Rheumatic Mitral Stenosis

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