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Phase 3Recruiting

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

Sponsored by Icahn School of Medicine at Mount Sinai

About this 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.

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, ischemic 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 i…

Where this study is enrolling (35)

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Who can participate

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

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Trial data sourced from ClinicalTrials.gov.