INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies
INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies
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.
Non-Inferiority Trial of rivaroxaban versus VKAs: 4,500 patients
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 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.
Rivaroxaban Arm
VKA Arm
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
Serious bleeding in the past six months or at high risk for bleeding
Moderate to severe hepatic impairment
Ongoing need for dual antiplatelet therapy (patients with on-going aspirin therapy ≤100 mg per day are not excluded)
Ongoing need for dual strong inhibitors of CYP-3a4 or p-glycoprotein inhibitor.
Received an investigational drug in the past 30 days
Patients considered unsuitable for trial inclusion because of unwillingness to attend follow up visits
Women who are pregnant and/or breastfeeding
Women of child bearing age who do not use an effective form of birth control.
Uberaba, Minas Gerais, Brazil
Guangzhou, Guangdong 510062, China
Bishkek, 720001, Kyrgyzstan
Culiacán, Sinaloa 80230, Mexico
Guerrero, 40000, Mexico