The aim of the study is to compare clinical outcomes between direct oral anticoagulant (DOAC) monotherapy versus dual antithrombotic therapy (DOAC plus clopidogrel) in patients with atrial fibrillation and acute myocardial infarction after percutaneous coronary intervention (PCI).
Patients aged 19 years old
Patients with AF and CHA2DS2-VA score ≥2.
ST-segment elevation myocardial infarction (STEMI) or Non-ST-segment elevation myocardial infarction (NSTEMI)
STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block.12
Patients contraindicated for use of DOACs or clopidogrel
Mechanical prosthetic valve or moderate-to-severe mitral stenosis requiring vitamin K antagonist
Planned cardiac surgery within 1 year after randomization
Patients with severe thrombocytopenia or coagulopathy
Parallel
DAT (DOAC+clopidogrel)
DrugPatients allocated to the DAT group receive either apixaban 5 mg twice daily, edoxaban 60 mg once daily, or rivaroxaban 15 mg once daily with clopidogrel 75 mg once daily.
DOAC monotherapy
DrugPatients allocated to the DOAC monotherapy group receive either apixaban 5 mg twice daily, edoxaban 60 mg once daily, or rivaroxaban 20 mg once daily.
NACE (net adverse clinical events)
a composite of death, non-fatal MI, stroke, systemic embolization, unplanned revascularization, stent thrombosis, major or clinically relevant non-major bleeding by ISTH
Rate of major bleeding by ISTH
major bleeding events by ISTH definition
Rate of MACCE (major adverse cardiac and cerebrovascular event)
a composite of cardiovascular death, non-fatal MI, ischemic stroke, systemic embolization, unplanned revascularization, and stent thrombosis
All-cause death
all-cause death
Cardiovascular death
cardiovascular death
Blood pressure control status
mean value, variability, and control rate of blood pressure
AF rhythm event
AF episode frequency and lasting time
AF burden (%)
AF burden (%)
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