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

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Aug 2, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at how well a medication called oral anticoagulation (OAC) works when added to standard care for patients who develop new-onset atrial fibrillation (a heart rhythm problem) after having heart surgery known as coronary artery bypass graft (CABG). The main goals are to see if this combination can help prevent serious complications like strokes, while also checking for any major bleeding risks that could occur from the medication.

To participate in the trial, candidates need to be at least 18 years old and have experienced atrial fibrillation that lasts for over an hour or happens multiple times within a week after their CABG surgery. Those who decide not to join the trial will still be included in a registry that tracks their treatment and health information. Participants will be monitored closely to ensure their safety and to gather valuable information that can help improve care for future patients. This trial is currently recruiting patients of all genders.

Gender

ALL

Eligibility criteria

• 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