Status:
RECRUITING
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Vanderbilt University Medical Center
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 t...
Detailed Description
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 comp...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
December 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
3200 Patients enrolled
Trial Details
Trial ID
NCT04045665
Start Date
December 13 2019
End Date
August 31 2026
Last Update
February 7 2025
Active Locations (96)
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1
CHI St. Vincent, Arkansas
Little Rock, Arkansas, United States, 72205
2
University of Southern California
Los Angeles, California, United States, 90033
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
Stanford University
Stanford, California, United States, 94305