Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
PACES
2 other identifiers
interventional
3,200
4 countries
101
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 atrial-fibrillation
Started Dec 2019
Longer than P75 for phase_3 atrial-fibrillation
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedStudy Start
First participant enrolled
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
January 20, 2026
January 1, 2026
6.7 years
August 2, 2019
January 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE)
Composite score of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (deep venous thrombosis and/or pulmonary embolism). Composite score calculated by number of events.
up to 180 days after randomization
Any BARC type 3 or 5
The Bleeding Academic Research Consortium (BARC) - any type 3 or 5 bleeding thrombosis and/or pulmonary. Type 3: a. Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding b. Overt bleeding plus hemoglobin drop \< 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents c. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision. type 5: a. Probable fatal bleeding b. Definite fatal bleeding (overt or autopsy or imaging confirmation)
90 days after randomization
Secondary Outcomes (11)
Net clinical benefit (NCB)
90 days after randomization
Number of participants with Ischemic Stroke event
180 days after randomization
Number of participants with TIA event
180 days after randomization
Number of participants with MI event
180 days after randomization
Number of participants with systematic arterial thromboembolism event
180 days after randomization
- +6 more secondary outcomes
Study Arms (2)
Antiplatelet Therapy
ACTIVE COMPARATORAntiplatelet-only strategy
Oral Anticoagulant
ACTIVE COMPARATOROAC-based strategy
Interventions
OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant OR apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Clinical history of either permanent, persistent or paroxysmal atrial fibrillation
- Any pre-existing clinical indication for long-term OAC
- Any absolute contraindication to OAC
- Planned use of post-operative dual antiplatelet therapy (DAPT)
- a. This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent.
- Cardiogenic shock
- Major perioperative complication\* occurring between CABG and randomization
- a. 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).
- 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
- Liver cirrhosis or Child-Pugh Class C chronic liver disease
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (101)
CHI St. Vincent, Arkansas
Little Rock, Arkansas, 72205, United States
University of Southern California
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford University
Stanford, California, 94305, United States
Medical Center of Aurora
Aurora, Colorado, 80012, United States
Western Connecticut Hospital Systems
Danbury, Connecticut, 06810, United States
Yale Medicine
New Haven, Connecticut, 06520-8039, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Emory University
Atlanta, Georgia, 30308, United States
Piedmont Healthcare Inc.
Atlanta, Georgia, 30309, United States
Lutheran Medical Center
Fort Wayne, Indiana, 46825, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Ascension St. Vincent
Indianapolis, Indiana, 46260, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Maine Medical Center
Portland, Maine, 04102, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Baystate Health
Springfield, Massachusetts, 01199, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Mid America Health Institute
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Northwell Health System
Great Neck, New York, 11023, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27858, United States
WakeMed
Raleigh, North Carolina, 27610, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Ascension St. John
Tulsa, Oklahoma, 74103, United States
University of Pittsburgh Medical Center
Hermitage, Pennsylvania, 16148, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030, United States
Baylor Research Institute
Plano, Texas, 75093, United States
Intermountain CV Research
Murray, Utah, 84107, United States
University of Utah
Salt Lake City, Utah, 84112, United States
University of Vermont
Burlington, Vermont, 05401, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Inova Health
Falls Church, Virginia, 22042, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
University of Alberta Hospital
Edmonton, Alberta, T6G2B7, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2W 1T8, Canada
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5, Canada
University of Ottawa Heart Institute
Ottawa, Canada
Hôpital Laval
Québec, G1V 4G5, Canada
Toronto General Hospital
Toronto, Canada
University Heart Center Hamburg
Berlin, Brandenburg, 11353, Germany
Heart Center Leipzig
Berlin, Brandenburg, 13347, Germany
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany
University Medical Center Jena
Jena, Thuringia, Germany
Kerckhoff Klinik, Bad Nauheim
Bad Nauheim, Germany
Clinic Bad Neustadt - Medical Center for Heart and Vascular Diseases
Bad Neustadt an der Saale, Germany
HDZ-NRW Bad Oeynhausen
Bad Oeynhausen, Germany
Charité Berlin - Benjamin Franklin Campus
Berlin, Germany
Charité Berlin - Rudolf Virchow Campus
Berlin, Germany
German Heart Center Berlin
Berlin, Germany
University Hospital Bonn
Bonn, Germany
Medical Center Braunschweig
Braunschweig, Germany
Heinrich Heine University Düsseldorf
Düsseldorf, Germany
Frankfurt University Hospital
Frankfurt, Germany
University Medical Center Frankfurt
Frankfurt, Germany
Heart Center, University of Freiburg
Freiburg im Breisgau, Germany
University Medical Center Halle
Halle, Germany
University Medical Center Heidelberg
Heidelberg, Germany
University Medical Center Schleswig-Holstein Kiel
Kiel, Germany
University Medical Center Schleswig-Holstein Lübeck
Lübeck, Germany
University Hospital Magdeburg
Magdeburg, Germany
German Heart Center Munich
Munich, Germany
Medical Center of the Ludwig-Maximilians-University Munich
Munich, Germany
University of Oldenburg
Oldenburg, Germany
Hospital of the Brothers of Mercy Trier
Trier, Germany
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, England, United Kingdom
Barts Health NHS Trust
London, England, United Kingdom
Imperial College Healthcare NHS Trust
London, England, United Kingdom
Royal Wolverhampton NHS Trust
Wolverhampton, England, United Kingdom
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, BS1 3NU, United Kingdom
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
Hull University Teaching Hospitals NHS Trust
Cottingham, HU16 5JQ, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, BN11 2DH, United Kingdom
Related Publications (2)
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.
PMID: 41609362DERIVEDTaha 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.
PMID: 33251914DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annetine C Gelijns, PhD
Icahn School of Medicine at Mount Sinai
- STUDY DIRECTOR
Marc Gillinov, MD
The Cleveland Clinic
- STUDY DIRECTOR
John Alexander, MD
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, Department of Population Health Science & Policy Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR
Study Record Dates
First Submitted
August 2, 2019
First Posted
August 5, 2019
Study Start
December 13, 2019
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- OtherDe-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.
- Access Criteria
- Anyone who wishes to access the data.Any purpose.Data are available indefinitely at (Link to be included).
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).