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Not Recruiting
Trial ID: NCT04045665
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Clinical Associate Professor, Cardiothoracic Surgery
Norman E. Shumway Professor, Professor of Cardiothoracic Surgery and, by courtesy, of Bioengineering
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
drug: Antiplatelet-only strategy
drug: Oral Anticoagulant plus background antiplatelet therapy
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Nicholas Vesom