Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG (PACES)

  • End date
    Dec 1, 2025
  • participants needed
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 18 October 2022
atrial fibrillation
antiplatelet therapy
vitamin k antagonist
coronary artery bypass graft
vitamin k
anticoagulation therapy


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.


This is a prospective, multicenter, open-label, randomized trial comparing OAC with no OAC (1:1 ratio) in patients who develop new-onset POAF after CABG. The primary effectiveness endpoint is the composite of death, stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) at 90 days after randomization. The primary safety endpoint is BARC (Bleeding Academic Research Consortium) grade 3 or 5 bleeding at 90 days after randomization. The overall intent is to evaluate the trade-off in prevention of thromboembolic events versus an increase in bleeding.

Patients will be randomly assigned to the following treatment strategies:

  • OAC-based strategy (experimental arm): OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant (apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
  • Antiplatelet-only strategy (control arm): single antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

The protocol-specified duration of anticoagulation is 90 days. Patients, who are randomized to the control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC. Accrual is expected to take 60 months. Study follow-up visits will be performed at 90 days and phone follow-up at 180 days.

Data for patients enrolled in the registry will be ascertained from the local clinical site via a review of medical records. The baseline risk profile of registry patients (i.e., patients eligible but unwilling to be randomized) will be analyzed and compared to that of patients randomized in the trial. The usage of anticoagulant and antiplatelet therapies in the registry population overall and baseline CHA2DS2-VASC stroke risk score will also be determined.

Patients will be offered the option of having biospecimens collected for future research.

Up to 500 patients will also be offered the option to participate in a digital health substudy which includes a wearable heart rhythm monitor device for 30 days post discharge.

Condition Atrial Fibrillation, Stroke, Bleeding
Treatment Antiplatelet-only strategy, Oral Anticoagulant plus background antiplatelet therapy
Clinical Study IdentifierNCT04045665
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on18 October 2022


Yes No Not Sure

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)
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
Including 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 (including aortic, mitral, tricuspid or pulmonary)
Concomitant or prior surgery for AF during CABG
Closure of an atrial septal defect or of a patent foramen ovale 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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