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

Atrial Fibrillation | Stroke | Bleeding

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 therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.

All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de 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

Lieu de l'étude

University of Alberta Hospital
University of Alberta Hospital
Edmonton, Alberta
Canada

Contactez l'équipe d'étude

Backup Contact

Steven Meyer, MD

Primary Contact

Tracy Jordan

[email protected]
Backup Contact

Celine Balay

[email protected]
Centre Hospitalier de l'Université de Montréal
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
Canada

Contactez l'équipe d'étude

Backup Contact

Nicolas Noiseux

Primary Contact

Joannie Dionne

[email protected]
Montreal Heart Institute
Montreal Heart Institute
Montreal, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Alexandre Bergeron

[email protected]
Backup Contact

Denis Bouchard, MD

London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Stephanie Fox

[email protected]
Backup Contact

Michael Chu

Hôpital du Sacré-Cœur de Montréal
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec
Canada

Contactez l'équipe d'étude

Sunnybrook Hospital
Sunnybrook Hospital
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Backup Contact

Stephen Fremes

Primary Contact

Reena Karkhanis

[email protected]
Étude parrainée par
Icahn School of Medicine at Mount Sinai
Participants recherchés
Plus d'informations
ID de l'étude: NCT04045665