Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04045665

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG

Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-01-20

3200

Participants Needed

101

Research Sites

350 weeks

Total Duration

On this page

Sponsors

I

Icahn School of Medicine at Mount Sinai

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older who have undergone isolated coronary artery bypass graft (CABG) surgery for coronary artery disease
  • New-onset post-operative atrial fibrillation (POAF) lasting more than 60 minutes or recurrent episodes within 7 days after CABG surgery
Not Eligible

You will not qualify if you...

  • History of permanent, persistent, or paroxysmal atrial fibrillation
  • Any existing reason for long-term oral anticoagulation therapy
  • Absolute contraindication to oral anticoagulation
  • Planned use of post-operative dual antiplatelet therapy, including recent stent placement
  • Cardiogenic shock
  • Major perioperative complications between CABG and randomization, such as stroke, TIA, myocardial infarction, major bleeding, severe sepsis, renal failure needing dialysis, or need for reoperation due to bleeding
  • Concurrent left atrial appendage closure during CABG
  • Concurrent valve surgery during or prior to CABG
  • Concurrent mitral valve annuloplasty during CABG
  • Concurrent carotid artery endarterectomy during CABG
  • Concurrent aortic root replacement during CABG
  • Surgery for atrial fibrillation during CABG
  • Liver cirrhosis or Child-Pugh Class C chronic liver disease
  • Use or planned use of investigational drugs or devices within 30 days prior to randomization or during the trial
  • Pregnancy at the time of randomization
  • Unable or unwilling to give informed consent
  • Unable or unwilling to follow study treatment and follow-up
  • Underlying disease limiting life expectancy to less than one year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 101 locations

1

CHI St. Vincent, Arkansas

Little Rock, Arkansas, United States, 72205

Actively Recruiting

2

University of Southern California

Los Angeles, California, United States, 90033

Actively Recruiting

3

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

4

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

5

Medical Center of Aurora

Aurora, Colorado, United States, 80012

Active, Not Recruiting

6

Western Connecticut Hospital Systems

Danbury, Connecticut, United States, 06810

Active, Not Recruiting

7

Yale Medicine

New Haven, Connecticut, United States, 06520-8039

Actively Recruiting

8

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

9

Emory University

Atlanta, Georgia, United States, 30308

Actively Recruiting

10

Piedmont Healthcare Inc.

Atlanta, Georgia, United States, 30309

Actively Recruiting

11

Lutheran Medical Center

Fort Wayne, Indiana, United States, 46825

Actively Recruiting

12

Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

13

Ascension St. Vincent

Indianapolis, Indiana, United States, 46260

Actively Recruiting

14

Ochsner Clinic

New Orleans, Louisiana, United States, 70121

Actively Recruiting

15

Maine Medical Center

Portland, Maine, United States, 04102

Actively Recruiting

16

University of Maryland

Baltimore, Maryland, United States, 21201

Actively Recruiting

17

Johns Hopkins

Baltimore, Maryland, United States, 21287

Actively Recruiting

18

Suburban Hospital

Bethesda, Maryland, United States, 20814

Actively Recruiting

19

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

20

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

21

Boston Medical Center

Boston, Massachusetts, United States, 02118

Active, Not Recruiting

22

Baystate Health

Springfield, Massachusetts, United States, 01199

Active, Not Recruiting

23

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

24

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

25

Mid America Health Institute

Kansas City, Missouri, United States, 64111

Actively Recruiting

26

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

27

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03766

Actively Recruiting

28

Jersey Shore University Medical Center

Neptune City, New Jersey, United States, 07753

Actively Recruiting

29

Northwell Health System

Great Neck, New York, United States, 11023

Actively Recruiting

30

The Mount Sinai Hospital

New York, New York, United States, 10029

Withdrawn

31

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

32

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

33

Duke University

Durham, North Carolina, United States, 27710

Actively Recruiting

34

East Carolina University

Greenville, North Carolina, United States, 27858

Actively Recruiting

35

WakeMed

Raleigh, North Carolina, United States, 27610

Withdrawn

36

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

37

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

38

Ascension St. John

Tulsa, Oklahoma, United States, 74103

Actively Recruiting

39

University of Pittsburgh Medical Center

Hermitage, Pennsylvania, United States, 16148

Withdrawn

40

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

41

Allegheny Health Network

Pittsburgh, Pennsylvania, United States, 15212

Active, Not Recruiting

42

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

43

Michael E. DeBakey VA Medical Center

Houston, Texas, United States, 77030

Actively Recruiting

44

Baylor Research Institute

Plano, Texas, United States, 75093

Actively Recruiting

45

Intermountain CV Research

Murray, Utah, United States, 84107

Actively Recruiting

46

University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

47

University of Vermont

Burlington, Vermont, United States, 05401

Actively Recruiting

48

University of Virginia Health System

Charlottesville, Virginia, United States, 22908

Actively Recruiting

49

Inova Health

Falls Church, Virginia, United States, 22042

Active, Not Recruiting

50

West Virginia University

Morgantown, West Virginia, United States, 26506

Actively Recruiting

51

University of Wisconsin

Madison, Wisconsin, United States, 53792

Active, Not Recruiting

52

University of Alberta Hospital

Edmonton, Alberta, Canada, T6G2B7

Actively Recruiting

53

London Health Sciences Centre

London, Ontario, Canada, N6A 5A5

Actively Recruiting

54

Sunnybrook Hospital

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

55

Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8

Actively Recruiting

56

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2W 1T8

Actively Recruiting

57

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada, H4J 1C5

Withdrawn

58

University of Ottawa Heart Institute

Ottawa, Canada

Not Yet Recruiting

59

Hôpital Laval

Québec, Canada, G1V 4G5

Actively Recruiting

60

Toronto General Hospital

Toronto, Canada

Not Yet Recruiting

61

University Heart Center Hamburg

Berlin, Brandenburg, Germany, 11353

Not Yet Recruiting

62

Heart Center Leipzig

Berlin, Brandenburg, Germany, 13347

Actively Recruiting

63

University Medical Center Göttingen

Göttingen, Lower Saxony, Germany

Not Yet Recruiting

64

University Medical Center Jena

Jena, Thuringia, Germany

Actively Recruiting

65

Kerckhoff Klinik, Bad Nauheim

Bad Nauheim, Germany

Actively Recruiting

66

Clinic Bad Neustadt - Medical Center for Heart and Vascular Diseases

Bad Neustadt an der Saale, Germany

Not Yet Recruiting

67

HDZ-NRW Bad Oeynhausen

Bad Oeynhausen, Germany

Not Yet Recruiting

68

Charité Berlin - Benjamin Franklin Campus

Berlin, Germany

Not Yet Recruiting

69

Charité Berlin - Rudolf Virchow Campus

Berlin, Germany

Not Yet Recruiting

70

German Heart Center Berlin

Berlin, Germany

Actively Recruiting

71

University Hospital Bonn

Bonn, Germany

Actively Recruiting

72

Medical Center Braunschweig

Braunschweig, Germany

Not Yet Recruiting

73

Heinrich Heine University Düsseldorf

Düsseldorf, Germany

Actively Recruiting

74

Frankfurt University Hospital

Frankfurt, Germany

Actively Recruiting

75

University Medical Center Frankfurt

Frankfurt, Germany

Not Yet Recruiting

76

Heart Center, University of Freiburg

Freiburg im Breisgau, Germany

Actively Recruiting

77

University Medical Center Halle

Halle, Germany

Actively Recruiting

78

University Medical Center Heidelberg

Heidelberg, Germany

Not Yet Recruiting

79

University Medical Center Schleswig-Holstein Kiel

Kiel, Germany

Not Yet Recruiting

80

University Medical Center Schleswig-Holstein Lübeck

Lübeck, Germany

Not Yet Recruiting

81

University Hospital Magdeburg

Magdeburg, Germany

Actively Recruiting

82

German Heart Center Munich

Munich, Germany

Not Yet Recruiting

83

Medical Center of the Ludwig-Maximilians-University Munich

Munich, Germany

Not Yet Recruiting

84

University of Oldenburg

Oldenburg, Germany

Actively Recruiting

85

Hospital of the Brothers of Mercy Trier

Trier, Germany

Actively Recruiting

86

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, England, United Kingdom

Actively Recruiting

87

Barts Health NHS Trust

London, England, United Kingdom

Actively Recruiting

88

Imperial College Healthcare NHS Trust

London, England, United Kingdom

Actively Recruiting

89

Royal Wolverhampton NHS Trust

Wolverhampton, England, United Kingdom

Actively Recruiting

90

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, United Kingdom

Actively Recruiting

91

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom, BS1 3NU

Actively Recruiting

92

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Actively Recruiting

93

Hull University Teaching Hospitals NHS Trust

Cottingham, United Kingdom, HU16 5JQ

Actively Recruiting

94

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Actively Recruiting

95

South Tees Hospitals NHS Foundation Trust

Middlesbrough, United Kingdom

Actively Recruiting

96

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Actively Recruiting

97

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom, OX3 9DU

Actively Recruiting

98

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Actively Recruiting

99

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Actively Recruiting

100

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Actively Recruiting

101

University Hospitals Sussex NHS Foundation Trust

Worthing, United Kingdom, BN11 2DH

Actively Recruiting

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Research Team

E

Ellen Moquete, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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