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

Overview

About this study

The purpose 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.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/25/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Paul Tang, M.D., Ph.D.

Open for enrollment

More information

Publications

Publications are currently not available
.
CLS-20598448

Mayo Clinic Footer