Preventing formation of blood clots due to atrial fibrillation, a cardiac arrhythmia that first occurred after coronary bypass surgery, with the help of anticoagulant medications.
- Conditions
- ew-Onset Post-Operative Atrial Fibrillation after CABGMedDRA version: 20.0Level: PTClassification code: 10003658Term: Atrial fibrillation Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-515924-35-00
- Lead Sponsor
- Icahn School Of Medicine At Mount Sinai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3200
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
Clinical history of either permanent, persistent or paroxysmal atrial fibrillation, 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 informed consent, Unable or unwilling to comply wit the study treatment and followup, Existence of underlying disease that limits life expectancy to less than one year, Women of childbearing potential (within two years after the last spontaneous menstruation) without effective contraceptive measures (Implanon, injections, oral contraceptives, intrauterine devices, vasectomized partner) during study participation. (Participants using hormone-based preparations must be informed about possible interactions with the study medication), Any pre-existing clinical indication for long-term OAC, Participation in other interventional studies, Patients under legal supervision or guardianship, Any absolute contraindication to OAC, Planned use of post-operative dual antiplatelet therapy (DAPT), Cardiogenic shock, Major perioperative complication occurring between CABG and randomization, Concomitant mitral valve annuloplasty during CABG, Concomitant valve surgery during CABG or prior valve surgery (including aortic, mitral, tricuspid or pulmonary), Concomitant mitral valve annuloplasty during CABG
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method