Trial of New Oral Anticoagulants vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation

2018P002307

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.

2019-04-30

2023-10-01

2023-10-01

Completed

Early phase I

100

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cardiac surgery patients who meet study criteria and develop recurrent or persistent atrial fibrillation post-operatively will be randomized 1:1 to receive Warfarin or Rivaroxaban for prophylaxis against stroke or other systemic arterial embolism', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Statisticians performing comparative analyses of primary outcomes will be blinded as to the allocation designations of patients. Otherwise there will be no masking in the study.'}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-10-24