Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Key facts
- Where
- São Paulo, BrazilSee the 4 sites
- Phase
- Phase 3
Where in Brazil
- Hospital Samaritano PaulistaSão Paulo, BrazilNo longer taking part
- Hospital Universitário São Francisco na Providência de DeusSão Paulo, BrazilNo longer taking part
- Instituto de Pesquisa Clínica de CampinasSão Paulo, BrazilNo longer taking part
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP-InCor-HCFMUSPSão Paulo, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Icahn School of Medicine at Mount Sinai
- Trial code
- NCT04045665EU 2024-515924-35-00
- Record updated
- 26 June 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Planned use of post-operative dual antiplatelet therapy (DAPT); This includes, but is not limited to, patients with recent PCI with drug-eluting or bare-metal stent; 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; 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; Clinical history of either permanent, persistent or paroxysmal atrial fibrillation; Major perioperative complication* occurring between CABG and randomization; 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); Liver cirrhosis or Child-Pugh Class C chronic liver disease; Existence of underlying disease that limits life expectancy to less than one year; Any pre-existing clinical indication for long-term OAC; Any absolute contraindication to OAC; Cardiogenic shock; 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.