Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Key facts
- Where
- Ann Arbor, Atlanta, Aurora, Baltimore, Bethesda, Boston, Burlington, Charlottesville, Cleveland, Columbus, Danbury, Durham, Falls Church, Fort Wayne, Great Neck, Greenville, Hermitage, Houston, Indianapolis, Kansas City, Lebanon, Little Rock, Los Angeles, Madison, Morgantown, Murray, Neptune City, New Haven, New Orleans, New York, Philadelphia, Pittsburgh, Plano, Portland, Raleigh, Rochester, Salt Lake City, Springfield, St Louis, Stanford, The Bronx, Tulsa, and Washington D.C., United StatesSee the 51 sites
- Phase
- Phase 3
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- Piedmont Healthcare, IncAtlanta, United StatesTaking people
- Medical Center of AuroraAurora, United StatesNo longer taking part
- Johns HopkinsBaltimore, United StatesTaking people
- University of MarylandBaltimore, United StatesTaking people
- Suburban HospitalBethesda, United StatesNo longer taking part
- Brigham and Women's HospitalBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- Boston Medical CenterBoston, United StatesNo longer taking part
- University of VermontBurlington, United StatesTaking people
- University of Virginia Health SystemCharlottesville, United StatesTaking people
- Cleveland Clinic FoundationCleveland, United StatesTaking people
- Ohio State University Medical CenterColumbus, United StatesNo longer taking part
- Western Connecticut Hospital SystemsDanbury, United StatesNo longer taking part
- Duke UniversityDurham, United StatesTaking people
- Inova HealthFalls Church, United StatesNo longer taking part
- Lutheran Medical CenterFort Wayne, United StatesNo longer taking part
- Northwell Health SystemGreat Neck, United StatesTaking people
- East Carolina UniversityGreenville, United StatesTaking people
- University of Pittsburgh Medical CenterHermitage, United StatesNo longer taking part
- Baylor College of MedicineHouston, United StatesTaking people
- Michael E. DeBakey VA Medical CenterHouston, United StatesTaking people
- Ascension St. VincentIndianapolis, United StatesNo longer taking part
- Indiana UniversityIndianapolis, United StatesNo longer taking part
- Mid America Health InstituteKansas City, United StatesTaking people
- Dartmouth Hitchcock Medical CenterLebanon, United StatesTaking people
- CHI St. Vincent, ArkansasLittle Rock, United StatesTaking people
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
- University of Southern CaliforniaLos Angeles, United StatesTaking people
- University of WisconsinMadison, United StatesNo longer taking part
- West Virginia UniversityMorgantown, United StatesTaking people
- Intermountain CV ResearchMurray, United StatesTaking people
- Jersey Shore University Medical CenterNeptune City, United StatesTaking people
- Yale MedicineNew Haven, United StatesTaking people
- Ochsner ClinicNew Orleans, United StatesTaking people
- Columbia University Medical CenterNew York, United StatesTaking people
- The Mount Sinai HospitalNew York, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Allegheny Health NetworkPittsburgh, United StatesNo longer taking part
- Baylor Research InstitutePlano, United StatesTaking people
- Maine Medical CenterPortland, United StatesTaking people
- WakemedRaleigh, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesTaking people
- University of UtahSalt Lake City, United StatesTaking people
- Baystate HealthSpringfield, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesTaking people
- Stanford UniversityStanford, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- Ascension St. JohnTulsa, United StatesNo longer taking part
- MedStar Washington Hospital CenterWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Icahn School of Medicine at Mount Sinai
- Trial code
- NCT04045665EU 2024-515924-35-00
- Record updated
- 26 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Patients of age ≥18 years who undergo isolated CABG for coronary artery disease; POAF that persists for >60 minutes or is recurrent (more than one episode) within 7 days after the index CABG surgery.
Exclusion: Planned use of post-operative dual antiplatelet therapy (DAPT); This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent; Concomitant left atrial appendage closure during CABG; Concomitant valve surgery during CABG or prior valve surgery (including aortic, mitral, tricuspid or pulmonary); Concomitant mitral valve annuloplasty during CABG; Concomitant carotid artery endarterectomy during CABG; Concomitant aortic root replacement during CABG; Concomitant surgery for AF during CABG; Pharmacologic therapy with an investigational drug or device within 30-days prior to randomization or plan to enroll patient in an investigational drug or device trial during participation in this trial; Clinical history of either permanent, persistent or paroxysmal atrial fibrillation; Major perioperative complication* occurring between CABG and randomization; including, but not limited to, stroke, TIA, MI, major bleeding (BARC type 4 bleeding), severe sepsis, renal failure requiring dialysis, or need for reoperation due to bleeding (e.g. pericardial tamponade); Liver cirrhosis or Child-Pugh Class C chronic liver disease; Existence of underlying disease that limits life expectancy to less than one year; Any pre-existing clinical indication for long-term OAC; Any absolute contraindication to OAC; Cardiogenic shock; Pregnancy at the time of randomization; Unable or unwilling to provide inform consent; Unable or unwilling to comply with the study treatment and follow-up.