No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
3,200 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
Who this trial is looking for
This trial is looking for patients who develop new atrial fibrillation after heart bypass surgery. Participants will receive a treatment to help prevent blood clots while monitoring their safety and health.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have had heart bypass surgery
I have had atrial fibrillation that lasted more than 60 minutes or happened more than once within 7 days after surgery
You may not be able to join if
I have a history of permanent or persistent atrial fibrillation
I need long-term anticoagulation therapy
I have major complications from my surgery
I am planning to take dual antiplatelet therapy after surgery
I have liver cirrhosis or severe liver disease
I am pregnant
I cannot provide informed consent
I have a disease that limits my life expectancy to less than one year
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 r…
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.
Trial Locations
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Status
Eligibility Criteria
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 …
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
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