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8110 Gatehouse Road, Falls Church, VA 22042

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after Coronary Artery Bypass Graft Surgery [PACeS]

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

N/A

Background Information

Evaluation of 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.

Offered At

Inova Heart and Vascular Institute
Inova Fairfax Medical Campus
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Eric L. Sarin MD

Eligibility Information

  • 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 original CABG surgery

Ineligibility Information

  • 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 (including aortic, mitral, tricuspid or pulmonary)
  • Concomitant surgery for AF during CABG
  • Closure of an atrial septal defect or of a patent foramen ovale during CABG
  • Stage IV or V chronic kidney disease (estimated glomerular filtration rate [eGFR]< 30 mL/min/1.73m2)
  • 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 informed 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

* This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent.

** Including 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).