Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective, randomized, active-controlled, parallel arm study compares the safety and financial benefits of arterial thromboembolism prophylaxis with Warfarin vs. Rivaroxaban (A novel oral anticoagulant) in patients with new onset atrial fibrillation after sternotomy for cardiac operations.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Anticoagulants; Rivaroxaban; Warfarin

Criteria

Inclusion Criteria:

• Male or Female ≥ 18 years

• At least one of the following procedures: coronary artery bypass grafting, aortic valve repair, mitral valve repair, non-mechanical aortic valve replacement, any combination of these procedures

• Two or more episodes of New Onset Atrial Fibrillation (each lasting > 20 minutes) or persistent atrial fibrillation lasting > 24 hours (Or for >18 hours over a 24-hour interval)

• If female of child-bearing age, use of adequate contraception

Exclusion Criteria:

• Pre-existing paroxysmal atrial fibrillation before cardiac surgery

• Pre-existing indications for therapeutic anticoagulation (Including but not limited to PE, DVT, mechanical valve)

• Moderate-to-severe mitral valve stenosis not surgically corrected

• Pre-existing allergy to study medications

• Recent (< 1 year) or ongoing pregnancy (Urine pregnancy test will be obtained for women of child bearing age at the time of enrollment into the study)

• Stroke within 1 month prior to surgery or postoperatively prior to initiation of study drugs

• Postoperative bleeding episode prior to initiation of study drug

• Severe dysfunction of another organ system including GFR < 30 ml/min, baseline INR > 1.7, ileus or other gastrointestinal pathology hindering ability to absorb oral medications, and known coagulation pathway deficiencies

• Postoperative need for non-aspirin anti-platelet therapy that cannot be discontinued when therapeutic anticoagulation is initiated

• Patient taking medications with known major interactions with study drugs with no therapeutic alternatives)