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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Antiplatelet-only strategy
  • Oral Anticoagulant plus background antiplatelet therapy

Treatment groups

3,200 Participants
are divided into 2 treatment groups

Locations

106
Brazil
Hospital Samaritano Paulista São Paulo Brazil
Hospital Universitário São Francisco na Providência de Deus São Paulo Brazil
Instituto de Pesquisa Clínica de Campinas São Paulo Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP-InCor-HCFMUSP São Paulo Brazil

Sponsors and collaborators

Icahn School of Medicine at Mount Sinai

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Vanderbilt University Medical Center

Collaborator