Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG (PACES)
J
Joel Corvera, MD
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
3
3200 participants needed
1 Location
Overview
The primary objective of this study is to evaluate the effectiveness (prevention ofhromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to
background antiplatelet therapy in patients who develop new-onset post-operative atrialbrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery.
All patients with a qualifying POAF event, who decline randomization, will be offered thegistry that captures their baseline risk profile andheir 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 effectivenessdpoint is the composite of death, ischemic stroke, transient ischemic attack (TIA),yocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE)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 intentvaluate 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) withzed ratio (INR) target 2-3 or any approved direct oralgulant (apixaban, rivaroxaban, edoxaban or dabigatran) in addition to backgroundherapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrelgrelor)
- Antiplatelet-only strategy (control arm): single antiplatelet therapy 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 randomizedhe control arm and develop recurrent AF after 30 days, may be crossed-over to an OAC.
Accrual is expected to take 60 months. Study follow-up visits will be performed at 90 daysd phone follow-up at days 30, 60, and 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.,gible but unwilling to be randomized) will be analyzed and compared to that ofdomized in the trial. The usage of anticoagulant and antiplatelet therapies inhe registry population overall and baseline CHA2DS2-VASC ischemic stroke risk score willbe determined.
Up to 500 patients will also be offered the option to participate in a digital healthubstudy which includes a wearable heart rhythm monitor device for 30 days post discharge.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Atrial Fibrillation, Stroke, Bleeding
-
Age: 18 Years
-
Gender: All
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 7days 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 orbare-metal stent.
- Cardiogenic shock
- Major perioperative complication* occurring between CABG and randomization
- including, but not limited to, stroke, TIA, MI, major bleeding (BARC type 4bleeding), severe sepsis, renal failure requiring dialysis, or need for reoperationdue to bleeding (e.g. pericardial tamponade).
- Concomitant left atrial appendage closure during CABG
- Concomitant valve surgery during CABG or prior valve surgery (including aortic,uspid 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 todomization or plan to enroll patient in an investigational drug or device trialduring 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
Updated on
01 Aug 2024.
Study ID: GCO 08-1078
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