Actively Recruiting
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-01-20
3200
Participants Needed
101
Research Sites
N/A
Total Duration
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
This research evaluates the use of oral anticoagulation (OAC) combined with background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. The study aims to assess how effectively this approach prevents thromboembolic events and its safety regarding major bleeding. Patients who decline randomization may join a parallel registry to capture their treatment choices and risk profiles. Participants will be randomly assigned to one of two treatment groups: an experimental arm receiving OAC (either a vitamin K antagonist or a direct oral anticoagulant) along with antiplatelet therapy, or a control arm receiving antiplatelet therapy alone. The anticoagulation treatment lasts 90 days, and patients in the control group who experience recurrent atrial fibrillation after 30 days may switch to OAC. Follow-up includes clinic visits at 90 days and phone calls at 30, 60, and 180 days. A digital health substudy involving a wearable heart monitor for 30 days post-discharge is also offered to some participants. During the study, researchers will monitor outcomes such as death, stroke, transient ischemic attack, myocardial infarction, and thromboembolism up to 180 days after randomization, along with bleeding events at 90 days. Data collection includes medical record reviews, risk profiling, and use of anticoagulants and antiplatelets. Safety and effectiveness will be analyzed by comparing the two treatment strategies. Participation may last up to six months, with assessments conducted in person and by phone.
CONDITIONS
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants receive either oral anticoagulants with background antiplatelet therapy or antiplatelet-only therapy following new-onset postoperative atrial fibrillation after CABG surgery.
Scheduled treatment visits as per assigned therapy
Duration - Up to 180 days after randomization
Participants are followed up to monitor for outcomes including thromboembolic events and bleeding, with visits and phone follow-ups after treatment ends.
Visits at 90 days and phone follow-ups at 30, 60, and 180 days
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
E
Ellen Moquete, RN
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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