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

Phase 3
Recruiting
Conditions
Atrial Fibrillation
Stroke
Bleeding
Registration Number
NCT04045665
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
3200
Inclusion Criteria

Inclusion Criteria:<br><br> - Patients of age =18 years who undergo isolated CABG for coronary artery disease<br><br> - POAF that persists for >60 minutes or is recurrent (more than one episode) within 7<br> days after the index CABG surgery<br><br>Exclusion Criteria:<br><br> - Clinical history of either permanent, persistent or paroxysmal atrial fibrillation<br><br> - Any pre-existing clinical indication for long-term OAC<br><br> - Any absolute contraindication to OAC<br><br> - Planned use of post-operative dual antiplatelet therapy (DAPT)<br><br> a. This includes, but is not limited to, patients with recent PCI with drug-eluting<br> or bare-metal stent.<br><br> - Cardiogenic shock<br><br> - Major perioperative complication* occurring between CABG and randomization<br><br> a. including, but not limited to, stroke, TIA, MI, major bleeding (BARC type 4<br> bleeding), severe sepsis, renal failure requiring dialysis, or need for reoperation<br> due to bleeding (e.g. pericardial tamponade).<br><br> - Concomitant left atrial appendage closure during CABG<br><br> - Concomitant valve surgery during CABG or prior valve surgery (including aortic,<br> mitral, tricuspid or pulmonary)<br><br> - Concomitant mitral valve annuloplasty during CABG<br><br> - Concomitant carotid artery endarterectomy during CABG<br><br> - Concomitant aortic root replacement during CABG<br><br> - Concomitant surgery for AF during CABG<br><br> - Liver cirrhosis or Child-Pugh Class C chronic liver disease<br><br> - Pharmacologic therapy with an investigational drug or device within 30-days prior to<br> randomization or plan to enroll patient in an investigational drug or device trial<br> during participation in this trial<br><br> - Pregnancy at the time of randomization<br><br> - Unable or unwilling to provide inform consent<br><br> - Unable or unwilling to comply with the study treatment and follow-up<br><br> - Existence of underlying disease that limits life expectancy to less than one year

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE);Any BARC type 3 or 5
Secondary Outcome Measures
NameTimeMethod
Net clinical benefit (NCB);Number of participants with Ischemic Stroke event;Number of participants with TIA event;Number of participants with MI event;Number of participants with systematic arterial thromboembolism event;Number of participants with venous thromboembolism event;Number of cardiovascular mortalities;Number of non-cardiovascular mortalities;The incidence of BARC 2 bleeding at 90 after randomization;The incidence of BARC 2 bleeding at 180 days after randomization;Number of cardiac arrhythmias
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