Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Icahn School of Medicine at Mount Sinai

Collaborator: Vanderbilt University Medical Center

Stanford Investigator(s):

Intervention(s):

  • Drug: Antiplatelet-only strategy
  • Drug: Oral Anticoagulant plus background antiplatelet therapy

Phase:

Phase 3

Eligibility


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 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 (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 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nicholas Vesom
Not Recruiting