Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Recruiting · NCT04045665 · Interventional (participants receive a specific treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →Interventions studied
Antiplatelet-only strategyOral Anticoagulant plus background antiplatelet therapy
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion 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
Exclusion criteria
- 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
- 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
Where it is running
60 locations listed across 27 US states.
- CHI St. Vincent, Arkansas - Little Rock, Arkansas, United States
- University of Southern California - Los Angeles, California, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Stanford University - Stanford, California, United States
- Medical Center of Aurora - Aurora, Colorado, United States
- Western Connecticut Hospital Systems - Danbury, Connecticut, United States
- Yale Medicine - New Haven, Connecticut, United States
- MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- Emory University - Atlanta, Georgia, United States
- Piedmont Healthcare Inc. - Atlanta, Georgia, United States
- Lutheran Medical Center - Fort Wayne, Indiana, United States
- Indiana University - Indianapolis, Indiana, United States
- Ascension St. Vincent - Indianapolis, Indiana, United States
- Ochsner Clinic - New Orleans, Louisiana, United States
- Maine Medical Center - Portland, Maine, United States
- University of Maryland - Baltimore, Maryland, United States
- Johns Hopkins - Baltimore, Maryland, United States
- Suburban Hospital - Bethesda, Maryland, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Boston Medical Center - Boston, Massachusetts, United States
- Baystate Health - Springfield, Massachusetts, United States
- University of Michigan - Ann Arbor, Michigan, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Mid America Health Institute - Kansas City, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Dartmouth-Hitchcock Medical Center - Lebanon, New Hampshire, United States
- Jersey Shore University Medical Center - Neptune City, New Jersey, United States
- Northwell Health System - Great Neck, New York, United States
- The Mount Sinai Hospital - New York, New York, United States
- Columbia University Medical Center - New York, New York, United States
- Montefiore Medical Center - The Bronx, New York, United States
- Duke University - Durham, North Carolina, United States
- East Carolina University - Greenville, North Carolina, United States
- WakeMed - Raleigh, North Carolina, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- Ohio State University Medical Center - Columbus, Ohio, United States
- Ascension St. John - Tulsa, Oklahoma, United States
- University of Pittsburgh Medical Center - Hermitage, Pennsylvania, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Allegheny Health Network - Pittsburgh, Pennsylvania, United States
- Baylor College of Medicine - Houston, Texas, United States
- Michael E. DeBakey VA Medical Center - Houston, Texas, United States
- Baylor Research Institute - Plano, Texas, United States
- Intermountain CV Research - Murray, Utah, United States
- University of Utah - Salt Lake City, Utah, United States
- University of Vermont - Burlington, Vermont, United States
- University of Virginia Health System - Charlottesville, Virginia, United States
- Inova Health - Falls Church, Virginia, United States
- West Virginia University - Morgantown, West Virginia, United States
- University of Wisconsin - Madison, Wisconsin, United States
- 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
- Blackpool Teaching Hospitals NHS Foundation Trust - Blackpool, United Kingdom
- University Hospital Bonn - Bonn, Germany
- Medical Center Braunschweig - Braunschweig, Germany
Showing 60 of 106 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →