Last updated on February 2020

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

Brief description of study

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.

Detailed Study Description

This is a prospective, multicenter, open-label, randomized trial comparing OAC with no OAC (1:1 ratio) in patients who develop new-onset POAF after CABG. The primary effectiveness endpoint is the composite of death, stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) at 90 days after randomization. The primary safety endpoint is BARC (Bleeding Academic Research Consortium) grade 3 or 5 bleeding at 90 days after randomization. The overall intent is to evaluate the trade-off in prevention of thromboembolic events versus an increase in bleeding.

Patients will be randomly assigned to the following treatment strategies:

  • OAC-based strategy (experimental arm): OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant (apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-100 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
  • Antiplatelet-only strategy (control arm): with aspirin 75-100 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

The protocol-specified duration of anticoagulation is 90 days. Patients, who are randomized to the control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC. Accrual is expected to take 36 months. Study follow-up visits will be performed at 90 days and phone follow-up at 180 days.

Data for patients enrolled in the registry will be ascertained from the local clinical site via a review of medical records. The baseline risk profile of registry patients (i.e., patients eligible but unwilling to be randomized) will be analyzed and compared to that of patients randomized in the trial. The usage of anticoagulant and antiplatelet therapies in the registry population overall and baseline CHA2DS2-VASC stroke risk score will also be determined.

Clinical Study Identifier: NCT04045665

Find a site near you

Start Over

CHI St. Vincent, Arkansas

Little Rock, AR United States
  Connect »

University of Southern California

Los Angeles, CA United States
  Connect »

Stanford University

Stanford, CA United States
  Connect »

Yale New Haven

New Haven, CT United States
  Connect »

Emory University

Atlanta, GA United States
  Connect »

Lutheran Medical Center

Fort Wayne, IN United States
  Connect »

Indiana University

Indianapolis, IN United States
  Connect »

Ochsner Clinic

New Orleans, LA United States
  Connect »

Maine Medical Center

Portland, ME United States
  Connect »

University of Maryland

Baltimore, MD United States
  Connect »

Suburban Hospital

Bethesda, MD United States
  Connect »

University of Michigan

Ann Arbor, MI United States
  Connect »

Mayo Clinic

Rochester, MN United States
  Connect »

Mid America Health Institute

Kansas City, MO United States
  Connect »

Northwell Health System

Great Neck, NY United States
  Connect »

The Mount Sinai Hospital

New York, NY United States
  Connect »

Mission Hospital

Asheville, NC United States
  Connect »

Duke University

Durham, NC United States
  Connect »

East Carolina University

Greenville, NC United States
  Connect »


Raleigh, NC United States
  Connect »

Cleveland Clinic Foundation

Cleveland, OH United States
  Connect »

University of Pennsylvania

Philadelphia, PA United States
  Connect »

Allegheny Health Network

Pittsburgh, PA United States
  Connect »

Baylor College of Medicine

Houston, TX United States
  Connect »

University of Utah

Salt Lake City, UT United States
  Connect »

University of Virginia Health System

Charlottesville, VA United States
  Connect »

Inova Health

Falls Church, VA United States
  Connect »

West Virginia University

Morgantown, WV United States
  Connect »

University of Wisconsin

Madison, WI United States
  Connect »

H pital Laval

Quebec, QC Canada
  Connect »

HDZ-NRW Bad Oeynhausen

Bad Oeynhausen, Germany
  Connect »