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

Launched by POPULATION HEALTH RESEARCH INSTITUTE · Jul 11, 2016

Keywords

ClinConnect Summary

Non-Inferiority Trial of rivaroxaban versus VKAs: 4,500 patients

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 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:

Pati...

Gender

ALL

Eligibility criteria

• 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
• • CHA2DS2-VASc score ≥ 2 OR
• • Moderate/Severe mitral stenosis with valve area ≤2.0 cm2 OR
• • Left atrial spontaneous echo contrast OR
• • Left atrial thrombus
• • 4. 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:
• • 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)
• • 8. Severe renal insufficiency with an calculated creatinine clearance (Cockcroft-Gault) \<15 ml/min
• • 9. Serious bleeding in the past six months or at high risk for bleeding
• • 10. Moderate to severe hepatic impairment
• • 11. Ongoing need for dual antiplatelet therapy (patients with on-going aspirin therapy ≤100 mg per day are not excluded)
• • 12. Ongoing need for dual strong inhibitors of CYP-3a4 or p-glycoprotein inhibitor.
• • 13. Received an investigational drug in the past 30 days
• • 14. Patients considered unsuitable for trial inclusion because of unwillingness to attend follow up visits
• • 15. Women who are pregnant and/or breastfeeding
• • 16. Women of child bearing age who do not use an effective form of birth control.