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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.
EU CTIS ID: 2024-515924-35-00
What this study is testing
The primary objective is 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 POAF after isolated CABG surgery.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- United Kingdom
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; United Kingdom; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.