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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
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

Full criteria on ClinicalTrials.gov

Sites (97)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto de Pesquisa Clínica de Campinas
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São PauloBrazilActive, not recruiting
Hospital Samaritano Paulista
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São PauloBrazilActive, not recruiting
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP-InCor-HCFMUSP
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São PauloBrazilActive, not recruiting
Hospital Universitário São Francisco na Providência de Deus
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São PauloBrazilActive, not recruiting
University of Alberta Hospital
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EdmontonCanadaRecruiting
London Health Sciences Centre
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LondonCanadaRecruiting
Montreal Heart Institute
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MontrealCanadaRecruiting
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaRecruiting
Hôpital du Sacré-Cœur de Montréal
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MontrealCanadaWithdrawn
University of Ottawa Heart Institute
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OttawaCanadaNot yet recruiting
Hôpital Laval
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QuébecCanadaRecruiting
Sunnybrook Hospital
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TorontoCanadaRecruiting
Toronto General Hospital
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TorontoCanadaNot yet recruiting
Universitaetsklinikum Aachen AöR
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AachenGermanyRecruiting
Kerckhoff-Klinik GmbH
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Bad NauheimGermanyRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Universitaetsklinikum Bonn AöR
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BonnGermanyRecruiting
Universitaetsklinikum Duesseldorf AöR
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DuesseldorfGermanyRecruiting
Goethe University Frankfurt
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Frankfurt Am MainGermanyRecruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyRecruiting
Martin-Luther-Universitaet Halle-Wittenberg
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Halle (Saale)GermanyRecruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyRecruiting
Friedrich-Schiller-Universitaet Jena
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JenaGermanyRecruiting
Herzzentrum Leipzig GmbH
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LeipzigGermanyRecruiting
Otto Von Guericke Universitaet Magdeburg
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MagdeburgGermanyRecruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyRecruiting
Deutsches Herzzentrum Muenchen Klinikum Der Technischen Universitaet Muenchen
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MunichGermanyRecruiting
Klinikum Oldenburg Aor
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OldenburgGermanyRecruiting
Barmherzige Brueder Trier gGmbH
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TrierGermanyRecruiting
Belfast Health and Social Care Trust
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BelfastUnited KingdomActive, not recruiting
Blackpool Teaching Hospitals NHS Foundation Trust
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BlackpoolUnited KingdomRecruiting
University Hospitals Bristol NHS Foundation Trust
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BristolUnited KingdomRecruiting
Royal Papworth Hospital NHS Foundation Trust
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CambridgeUnited KingdomActive, not recruiting
Hull University Teaching Hospitals NHS Trust
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CottinghamUnited KingdomActive, not recruiting
University Hospitals of Leicester NHS Trust
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LeicesterUnited KingdomActive, not recruiting
Liverpool Heart and Chest Hospital NHS Foundation Trust
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LiverpoolUnited KingdomRecruiting
Imperial College Healthcare NHS Trust
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LondonUnited KingdomRecruiting
Barts Health NHS Trust
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LondonUnited KingdomRecruiting
South Tees Hospitals NHS Foundation Trust
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MiddlesbroughUnited KingdomRecruiting
Nottingham University Hospitals NHS Trust
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NottinghamUnited KingdomRecruiting
Oxford University Hospitals NHS Foundation Trust
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OxfordUnited KingdomActive, not recruiting
University Hospitals Plymouth NHS Trust
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PlymouthUnited KingdomActive, not recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
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SheffieldUnited KingdomActive, not recruiting
University Hospital Southampton NHS Foundation Trust
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SouthamptonUnited KingdomRecruiting
Royal Wolverhampton Nhs Trust
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WolverhamptonUnited KingdomRecruiting
University Hospitals Sussex NHS Foundation Trust
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WorthingUnited KingdomRecruiting
University of Michigan
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Ann ArborUnited StatesRecruiting
Emory University
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AtlantaUnited StatesRecruiting
Piedmont Healthcare, Inc
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AtlantaUnited StatesRecruiting
Medical Center of Aurora
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AuroraUnited StatesActive, not recruiting
Johns Hopkins
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BaltimoreUnited StatesRecruiting
University of Maryland
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BaltimoreUnited StatesRecruiting
Suburban Hospital
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BethesdaUnited StatesActive, not recruiting
Massachusetts General Hospital
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BostonUnited StatesRecruiting
Boston Medical Center
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BostonUnited StatesActive, not recruiting
Brigham and Women's Hospital
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BostonUnited StatesRecruiting
University of Vermont
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BurlingtonUnited StatesRecruiting
University of Virginia Health System
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CharlottesvilleUnited StatesRecruiting
Cleveland Clinic Foundation
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ClevelandUnited StatesRecruiting
Ohio State University Medical Center
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ColumbusUnited StatesActive, not recruiting
Western Connecticut Hospital Systems
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DanburyUnited StatesActive, not recruiting
Duke University
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DurhamUnited StatesRecruiting
Inova Health
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Falls ChurchUnited StatesActive, not recruiting
Lutheran Medical Center
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Fort WayneUnited StatesActive, not recruiting
Northwell Health System
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Great NeckUnited StatesRecruiting
East Carolina University
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GreenvilleUnited StatesRecruiting
University of Pittsburgh Medical Center
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HermitageUnited StatesWithdrawn
Baylor College of Medicine
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HoustonUnited StatesRecruiting
Michael E. DeBakey VA Medical Center
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HoustonUnited StatesRecruiting
Indiana University
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IndianapolisUnited StatesActive, not recruiting
Ascension St. Vincent
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IndianapolisUnited StatesActive, not recruiting
Mid America Health Institute
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Kansas CityUnited StatesRecruiting
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesRecruiting
CHI St. Vincent, Arkansas
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Little RockUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
University of Southern California
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Los AngelesUnited StatesRecruiting
University of Wisconsin
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MadisonUnited StatesActive, not recruiting
West Virginia University
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MorgantownUnited StatesRecruiting
Intermountain CV Research
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MurrayUnited StatesRecruiting
Jersey Shore University Medical Center
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Neptune CityUnited StatesRecruiting
Yale Medicine
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New HavenUnited StatesRecruiting
Ochsner Clinic
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New OrleansUnited StatesRecruiting
The Mount Sinai Hospital
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New YorkUnited StatesWithdrawn
Columbia University Medical Center
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New YorkUnited StatesRecruiting
University of Pennsylvania
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PhiladelphiaUnited StatesRecruiting
Allegheny Health Network
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PittsburghUnited StatesActive, not recruiting
Baylor Research Institute
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PlanoUnited StatesRecruiting
Maine Medical Center
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PortlandUnited StatesRecruiting
Wakemed
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RaleighUnited StatesWithdrawn
Mayo Clinic
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RochesterUnited StatesRecruiting
University of Utah
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Salt Lake CityUnited StatesRecruiting
Baystate Health
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SpringfieldUnited StatesActive, not recruiting
Stanford University
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StanfordUnited StatesRecruiting
Washington University School of Medicine
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St LouisUnited StatesRecruiting
Montefiore Medical Center
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The BronxUnited StatesRecruiting
Ascension St. John
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TulsaUnited StatesActive, not recruiting
MedStar Washington Hospital Center
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Washington D.C.United StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.