CompletedPhase 3

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

Botswana, Brazil4,565 participantsStarted 2016-08-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. RVHD diagnosed by echocardiography at any time prior to enrollment
✓. Age ≥18
✓. Increased risk of stroke by any of the following
✓. Heart Rhythm \*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.

Exclusion criteria

✕. Refusal to give informed consent
✕. Actively involved in any study that would compromise the protocol of INVICTUS Trial
✕. Severe co-morbid condition with life expectancy \< 1 year
✕. 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.
✕. Likely to have valve replacement surgery within 6 months
✕. 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.
✕. Contraindication to the study medication of the trial
✕. Severe renal insufficiency with an calculated creatinine clearance (Cockcroft-Gault) \<15 ml/min

What they're measuring

Time from randomization to the first occurrence of vascular death or death of unknown cause, stroke, myocardial infarction or systemic embolism

Timeframe: Approximately 4 years

Trial details

NCT IDNCT02832544

SponsorPopulation Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-18

View on ClinicalTrials.gov More Rheumatic Heart Disease trials