About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Antiplatelet-only strategy
- Oral Anticoagulant plus background antiplatelet therapy
Treatment groups
Locations
106Sponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Vanderbilt University Medical Center
Collaborator