NCT04045665RecruitingPhase 3
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 3200 (estimated)
- First submitted
- 2 Aug 2019
- Start date
- 13 Dec 2019
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT04045665
- EU CT number
- 2024-515924-35-00
- EudraCT number
- 2021-005022-18
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 3200
- From 13 Dec 2019 to the primary completion date, 31 Aug 2026
- 97 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (97)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Pesquisa Clínica de Campinas Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| Hospital Samaritano Paulista Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP-InCor-HCFMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| Hospital Universitário São Francisco na Providência de Deus Coordinator of this site? Confirm its status | São Paulo | Brazil | Active, not recruiting |
| University of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Hôpital du Sacré-Cœur de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Withdrawn |
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Not yet recruiting |
| Hôpital Laval Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Sunnybrook Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| Universitaetsklinikum Aachen AöR Coordinator of this site? Confirm its status | Aachen | Germany | Recruiting |
| Kerckhoff-Klinik GmbH Coordinator of this site? Confirm its status | Bad Nauheim | Germany | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Recruiting |
| Goethe University Frankfurt Coordinator of this site? Confirm its status | Frankfurt Am Main | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Martin-Luther-Universitaet Halle-Wittenberg Coordinator of this site? Confirm its status | Halle (Saale) | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Friedrich-Schiller-Universitaet Jena Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Herzzentrum Leipzig GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Otto Von Guericke Universitaet Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Deutsches Herzzentrum Muenchen Klinikum Der Technischen Universitaet Muenchen Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum Oldenburg Aor Coordinator of this site? Confirm its status | Oldenburg | Germany | Recruiting |
| Barmherzige Brueder Trier gGmbH Coordinator of this site? Confirm its status | Trier | Germany | Recruiting |
| Belfast Health and Social Care Trust Coordinator of this site? Confirm its status | Belfast | United Kingdom | Active, not recruiting |
| Blackpool Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Recruiting |
| University Hospitals Bristol NHS Foundation Trust Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Royal Papworth Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Active, not recruiting |
| Hull University Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Cottingham | United Kingdom | Active, not recruiting |
| University Hospitals of Leicester NHS Trust Coordinator of this site? Confirm its status | Leicester | United Kingdom | Active, not recruiting |
| Liverpool Heart and Chest Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| South Tees Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Recruiting |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Recruiting |
| Oxford University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Oxford | United Kingdom | Active, not recruiting |
| University Hospitals Plymouth NHS Trust Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Active, not recruiting |
| Sheffield Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Active, not recruiting |
| University Hospital Southampton NHS Foundation Trust Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
| Royal Wolverhampton Nhs Trust Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Recruiting |
| University Hospitals Sussex NHS Foundation Trust Coordinator of this site? Confirm its status | Worthing | United Kingdom | Recruiting |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Piedmont Healthcare, Inc Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Medical Center of Aurora Coordinator of this site? Confirm its status | Aurora | United States | Active, not recruiting |
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| University of Maryland Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Suburban Hospital Coordinator of this site? Confirm its status | Bethesda | United States | Active, not recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Active, not recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Vermont Coordinator of this site? Confirm its status | Burlington | United States | Recruiting |
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Ohio State University Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Active, not recruiting |
| Western Connecticut Hospital Systems Coordinator of this site? Confirm its status | Danbury | United States | Active, not recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Inova Health Coordinator of this site? Confirm its status | Falls Church | United States | Active, not recruiting |
| Lutheran Medical Center Coordinator of this site? Confirm its status | Fort Wayne | United States | Active, not recruiting |
| Northwell Health System Coordinator of this site? Confirm its status | Great Neck | United States | Recruiting |
| East Carolina University Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Hermitage | United States | Withdrawn |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Michael E. DeBakey VA Medical Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Active, not recruiting |
| Ascension St. Vincent Coordinator of this site? Confirm its status | Indianapolis | United States | Active, not recruiting |
| Mid America Health Institute Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
| CHI St. Vincent, Arkansas Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Active, not recruiting |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
| Intermountain CV Research Coordinator of this site? Confirm its status | Murray | United States | Recruiting |
| Jersey Shore University Medical Center Coordinator of this site? Confirm its status | Neptune City | United States | Recruiting |
| Yale Medicine Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Ochsner Clinic Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| The Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Withdrawn |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Allegheny Health Network Coordinator of this site? Confirm its status | Pittsburgh | United States | Active, not recruiting |
| Baylor Research Institute Coordinator of this site? Confirm its status | Plano | United States | Recruiting |
| Maine Medical Center Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Wakemed Coordinator of this site? Confirm its status | Raleigh | United States | Withdrawn |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Baystate Health Coordinator of this site? Confirm its status | Springfield | United States | Active, not recruiting |
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
| Ascension St. John Coordinator of this site? Confirm its status | Tulsa | United States | Active, not recruiting |
| MedStar Washington Hospital Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.