RecruitingPhase 3

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

United States, Brazil, Canada3,200 participantsStarted 2019-12-13

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 de…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE)

Timeframe: up to 180 days after randomization

Any BARC type 3 or 5

Timeframe: 90 days after randomization

Trial details

NCT IDNCT04045665

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Jonathan Hupf

(212) 659-6862 Jonathan.Hupf@mountsinai.org

View on ClinicalTrials.gov More Atrial Fibrillation trials