RECRUITING

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

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Conditions

Atrial FibrillationStrokeBleedingAnticoagulationAntiplatelet TherapyPost Operative Atrial Fibrillation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-12-13
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04045665

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients of age ≥18 years who undergo isolated CABG for coronary artery disease
  2. * POAF that persists for \>60 minutes or is recurrent (more than one episode) within 7 days after the index CABG surgery
  1. * Clinical history of either permanent, persistent or paroxysmal atrial fibrillation
  2. * Any pre-existing clinical indication for long-term OAC
  3. * Any absolute contraindication to OAC
  4. * Planned use of post-operative dual antiplatelet therapy (DAPT)
  5. * Cardiogenic shock
  6. * Major perioperative complication\* occurring between CABG and randomization
  7. * Concomitant left atrial appendage closure during CABG
  8. * Concomitant valve surgery during CABG or prior valve surgery (including aortic, mitral, tricuspid or pulmonary)
  9. * Concomitant mitral valve annuloplasty during CABG
  10. * Concomitant carotid artery endarterectomy during CABG
  11. * Concomitant aortic root replacement during CABG
  12. * Concomitant surgery for AF during CABG
  13. * Liver cirrhosis or Child-Pugh Class C chronic liver disease
  14. * 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
  15. * Pregnancy at the time of randomization
  16. * Unable or unwilling to provide inform consent
  17. * Unable or unwilling to comply with the study treatment and follow-up
  18. * Existence of underlying disease that limits life expectancy to less than one year

Contacts and Locations

Study Contact

Ellen Moquete, RN
CONTACT
212-659-9651
ellen.moquete@mountsinai.org

Principal Investigator

Annetine C Gelijns, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Marc Gillinov, MD
STUDY_DIRECTOR
The Cleveland Clinic
John Alexander, MD
STUDY_DIRECTOR
Duke University

Study Locations (Sites)

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, 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
Saint Louis, Missouri, 63110
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
United States
Jersey Shore University Medical Center
Neptune, New Jersey, 07753
United States
Montefiore Medical Center
Bronx, New York, 10467
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
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
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

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Annetine C Gelijns, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Marc Gillinov, MD, STUDY_DIRECTOR, The Cleveland Clinic
  • John Alexander, MD, STUDY_DIRECTOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-13
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2019-12-13
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Anticoagulation
  • Antiplatelet Therapy
  • Post Operative Atrial Fibrillation

Additional Relevant MeSH Terms

  • Atrial Fibrillation
  • Stroke
  • Bleeding