drugset / Trial / NCT04045665
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Phase 3
Recruiting
3200 enrolled
Icahn School of Medicine at Mount Sinai
National Heart, Lung, and Blood Institute (NHLBI) · collabVanderbilt University Medical Center · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.
Timeline
- Start
- 2019-12-13
- Primary completion
- 2026-08-31
- Completion
- 2026-08-31
Publications
- Budd AN, Kertai MD, Wyler von Ballmoos MC, Raphael J, Ghadimi K, Levy JH, Shore-Lesserson LJ, Mazzeffi MA, Sniecinski RM, Tanaka KA, Bolliger D, Abdalla M, Ural KG, Upchurch PA, Rozental O, Hunter CB, Seibert AR, Klick JC, Carroll D, Lobner K, Hensley NB. Management of Direct Oral Anticoagulants in Adult Patients Undergoing Cardiac Surgery: A Joint Consensus Statement by the Society of Cardiovascular Anesthesiologists and the Society of Thoracic Surgeons. Anesth Analg. 2026 Apr 1;142(4):668-681. doi: 10.1213/ANE.0000000000007868. Epub 2026 Jan 29.
- Boriani G, Imberti JF, McIntyre WF, Mei DA, Healey JS, Schnabel RB, Svennberg E, Camm AJ, Freedman B. Detection and management of postoperative atrial fibrillation after coronary artery bypass grafting or non-cardiac surgery: a survey by the AF-SCREEN International Collaboration. Intern Emerg Med. 2025 Apr;20(3):739-749. doi: 10.1007/s11739-025-03861-2. Epub 2025 Feb 8.
- Taha A, Nielsen SJ, Bergfeldt L, Ahlsson A, Friberg L, Bjorck S, Franzen S, Jeppsson A. New-Onset Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Outcome: A Population-Based Nationwide Study From the SWEDEHEART Registry. J Am Heart Assoc. 2021 Jan 5;10(1):e017966. doi: 10.1161/JAHA.120.017966. Epub 2020 Nov 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | — | Oral |
| Subject | Dabigatran | Unknown | — | Oral |
| Subject | Edoxaban | Small molecule | — | Oral |
| Subject | Rivaroxaban | Other / unclassified | — | Oral |
| Background | Aspirin | Small molecule | — | — |
| Background | Clopidogrel | Small molecule | — | — |
| Background | Ticagrelor | Small molecule | — | — |