Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Icahn School of Medicine at Mount Sinai
3,200 participants
Dec 13, 2019
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- 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 Criteria20
- 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
Interventions
Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant OR apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
Locations(101)
View Full Details on ClinicalTrials.gov
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NCT04045665