Phase 3
Completed N=100
Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation
Source: ClinicalTrials.gov NCT03702582 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Postoperative Length of Stay — 8; 7 days
◆ Published Evidence
Emerging
9citations · ~2 / year
Rationale and Design of the Randomized Controlled Trial of New Oral Anticoagulants Versus Warfarin for Post Cardiac Surgery Atrial Fibrillation: The NEW-AF Trial.
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.
Linked Publications
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Rationale and Design of the Randomized Controlled Trial of New Oral Anticoagulants Versus Warfarin for Post Cardiac Surgery Atrial Fibrillation: The NEW-AF Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Length of Stay |
8; 7 | — |
| SECONDARY Episode of Major Bleeding (Defined as the Occurrence of Any of Several Events Listed in the Description. No Specific Scale, Questionnaire or Instrument Will be Used) |
0; 0 | — |
| SECONDARY Cerebrovascular Accident (CVA) |
0; 0 | — |
| SECONDARY Other Systemic Embolism |
0; 0 | — |
| SECONDARY Deep Venous Thrombosis (DVT) and/or Pulmonary Embolism (PE) |
0; 0 | — |
| SECONDARY Minor Bleeding |
1; 3 | — |
| SECONDARY Performance on the EUROQOL (EQ-5D) Quality of Life Instrument |
35; 26; 8; 19; 0; 0 | — |
| SECONDARY Performance on the EUROQOL (EQ-5D) Quality of Life Instrument - VAS |
75; 75 | — |
| SECONDARY Average Score on the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) |
83.1; 86.9 | — |
Eligibility 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 ( 1.7, 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)
Data sourced from ClinicalTrials.gov (NCT03702582) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.