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Atrial FibrillationDigital healthDrugPhase 3

What this study is

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.

What's being tested

  • Antiplatelet-only strategy

    Intervention · DRUG

    Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)

  • Oral Anticoagulant plus background antiplatelet therapy

    Intervention · DRUG

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

Study details

Sponsor
Icahn School of Medicine at Mount Sinai
Conditions
Atrial Fibrillation · Stroke · Bleeding
Enrolling
3,200 people
Starts
2019-12-13
Est. completion
2026-08-31
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗