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

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.

Conditions

Atrial Fibrillation, Stroke, Bleeding

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Little Rock

CHI St. Vincent, Arkansas, Little Rock, Arkansas, United States, 72205

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Stanford

Stanford University, Stanford, California, United States, 94305

Aurora

Medical Center of Aurora, Aurora, Colorado, United States, 80012

Danbury

Western Connecticut Hospital Systems, Danbury, Connecticut, United States, 06810

New Haven

Yale Medicine, New Haven, Connecticut, United States, 06520-8039

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Atlanta

Emory University, Atlanta, Georgia, United States, 30308

Atlanta

Piedmont Healthcare Inc., Atlanta, Georgia, United States, 30309

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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)
  • * Cardiogenic shock
  • * Major perioperative complication\* occurring between CABG and randomization
  • * 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
  • * 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
  • * 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
  • * Existence of underlying disease that limits life expectancy to less than one year

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2025-06-30