Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
This study is looking at whether adding oral anticoagulants (blood thinners like apixaban, rivaroxaban, edoxaban, dabigatran, or warfarin) to standard antiplatelet therapy (aspirin or clopidogrel/ticagrelor) is better and safer for patients who develop new atrial fibrillation (an irregular heartbeat) after coronary artery bypass graft (CABG) surgery. Researchers want to see if this combination prevents serious problems like stroke, heart attack, or blood clots, while also checking for major bleeding. You might be able to join if you are 18 or older, had isolated CABG surgery, and developed new atrial fibrillation that lasted over 60 minutes or happened more than once within 7 days after your surgery. The study is currently recruiting 3200 participants, but the overall status is unclear.
- Study design
- This is an interventional study where participants are randomly assigned to receive either oral anticoagulants plus antiplatelet therapy, or antiplatelet therapy alone. It is an open-label study, meaning both you and your doctors will know which treatment you are receiving.
- What's involved
- You would receive either oral anticoagulants plus antiplatelet therapy or antiplatelet therapy alone for 90 days. The study will track your health for up to 180 days after you are assigned to a treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 180 days after they are assigned to a treatment to monitor for serious events and bleeding.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
At a glance
Conditions
Where it's being run
106 sites across 39 statesStudy leadership
- Annetine C Gelijns, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
- Marc Gillinov, MD · STUDY_DIRECTOR · The Cleveland Clinic
- John Alexander, MD · STUDY_DIRECTOR · Duke University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Composite of death, ischemic stroke, TIA, MI, systemic arterial thromboembolism or venous thromboembolism (DVT and/or PE)up to 180 days after randomization
Composite score of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (deep venous thrombosis and/or pulmonary embolism). Composite score calculated by number of events.
- Any BARC type 3 or 590 days after randomization
The Bleeding Academic Research Consortium (BARC) - any type 3 or 5 bleeding thrombosis and/or pulmonary. Type 3: a. Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL (provided hemoglobin drop is related to bleed); transfusion with overt bleeding b. Overt bleeding plus hemoglobin drop \< 5 g/dL (provided hemoglobin drop is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents c. Intracranial hemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision. type 5: a. Probable fatal bleeding b. Definite fatal bleeding (overt or autopsy or imaging confirmation)