What is the Purpose of this Study?
This study focuses on individuals who have undergone recent coronary artery bypass graft surgery (CABG), also known as bypass surgery. The purpose of the study is to compare 2 commonly used treatment strategies for the prevention of thromboembolic events (blood clots) in patients with new post-operative atrial fibrillation. Atrial fibrillation is the most common type of irregular heartbeat that occurs in some patients after they undergo CABG. It can develop when the upper chambers of the heart (atria) produce a disorganized electrical activity, which then causes the heart to beat irregularly. Patients who have this heartbeat irregularity are at a higher risk of developing blood clots in the heart. There are 2 classes of drugs for preventing blood clots: antiplatelet drugs (such as aspirin, clopidogrel or ticagrelor) and anticoagulants (blood thinners such as coumadin, apixaban, rivaroxaban, edoxaban or dabigatran).
Participants will be randomly assigned to 1 of 2 groups. One group will receive an antiplatelet drug alone, and the other will receive an anticoagulant drug in addition to the antiplatelet drug. All drugs used in this study are approved by the U.S Food and Drug Administration (FDA) for patients with atrial fibrillation.
Eligibility
- * 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
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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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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG