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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    3200
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 24 February 2021
aspirin
anticoagulants
atrial fibrillation
ticagrelor
clopidogrel
antiplatelet therapy
rivaroxaban
fibrillation
vitamin k antagonist
coronary artery bypass graft
vitamin k
thromboembolism
apixaban
edoxaban
dabigatran
anticoagulation therapy

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 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.

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 composite of death, stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) at 90 days after randomization. The primary safety endpoint is BARC (Bleeding Academic Research Consortium) grade 3 or 5 bleeding at 90 days after randomization. The overall intent is to evaluate the trade-off in prevention of thromboembolic events versus an increase in bleeding.

Patients will be randomly assigned to the following treatment strategies:

  • OAC-based strategy (experimental arm): OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant (apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
  • Antiplatelet-only strategy (control arm): with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

The protocol-specified duration of anticoagulation is 90 days. Patients, who are randomized to the control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC. Accrual is expected to take 36 months. Study follow-up visits will be performed at 90 days and phone follow-up at 180 days.

Data for patients enrolled in the registry will be ascertained from the local clinical site via a review of medical records. The baseline risk profile of registry patients (i.e., patients eligible but unwilling to be randomized) will be analyzed and compared to that of patients randomized in the trial. The usage of anticoagulant and antiplatelet therapies in the registry population overall and baseline CHA2DS2-VASC stroke risk score will also be determined.

Patients will be offered the option of having biospecimens collected for future research.

Details
Condition Arrhythmia, Hemorrhage, Atrial Fibrillation, Cerebrovascular accident, Atrial Fibrillation (Pediatric), Stroke, Dysrhythmia, cerebrovascular accidents, strokes, cerebral
Treatment Antiplatelet-only strategy, Oral Anticoagulant plus background antiplatelet therapy
Clinical Study IdentifierNCT04045665
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on24 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Cerebrovascular accident or Arrhythmia or Hemorrhage or Dysrhythmia or Atrial Fibrillation or Stroke or Atrial Fibrillation (Pediatric)?
Do you have any of these conditions: Dysrhythmia or Atrial Fibrillation (Pediatric) or Atrial Fibrillation or Cerebrovascular accident or cerebrovascular accidents or strokes, cerebral or...?
Do you have any of these conditions: strokes, cerebral or Atrial Fibrillation (Pediatric) or Cerebrovascular accident or cerebrovascular accidents or Arrhythmia or Dysrhythmia or Stroke o...?
Do you have any of these conditions: Atrial Fibrillation or Cerebrovascular accident or strokes, cerebral or Dysrhythmia or Atrial Fibrillation (Pediatric) or Stroke or Arrhythmia or cere...?
Do you have any of these conditions: cerebrovascular accidents or Dysrhythmia or strokes, cerebral or Atrial Fibrillation (Pediatric) or Cerebrovascular accident or Atrial Fibrillation or...?
Do you have any of these conditions: Dysrhythmia or Atrial Fibrillation (Pediatric) or Cerebrovascular accident or Hemorrhage or Stroke or Atrial Fibrillation or Arrhythmia or cerebrovasc...?
Do you have any of these conditions: Atrial Fibrillation (Pediatric) or Atrial Fibrillation or Arrhythmia or Hemorrhage or Stroke or Dysrhythmia or cerebrovascular accidents or strokes, c...?
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)
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
Including 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 (including aortic, mitral, tricuspid or pulmonary)
Concomitant or prior surgery for AF during CABG
Closure of an atrial septal defect or of a patent foramen ovale during CABG
Stage IV or V chronic kidney disease (estimated glomerular filtration rate [eGFR]<30 mL/min/1.73m2)
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
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