EPIDAURUS
Escalated Single Platelet Inhibition for One Month Plus Direct Oral Anticoagulation in Patients With Atrial Fibrillation and acUte coRonary Syndrome Undergoing percutaneoUS Coronary Intervention (EPIDAURUS)
Patient / Population Intervention / Exposition Comparaison Critère de jugement
In 602 patients with atrial fibrillation and ACS after PCI, one month of a potent P2Y12 inhibitor plus a NOAC was compared with clopidogrel plus a NOAC on major ischaemic events at 6 weeks.
N
602
Schéma
Investigator-initiated, multicentre, randomised, open-label trial with blinded outcome assessment (sponsor LMU Munich); 1:1 randomisation within 24 hours of successful PCI; co-primary endpoints at 6 weeks tested for superiority (ischaemic composite) and non-inferiority (death or bleeding)
Critère
Co-primary at 6 weeks — (1) major ischaemic events, the composite of all-cause death, myocardial infarction, definite or probable stent thrombosis, ischaemic stroke, systemic thromboembolism or urgent revascularisation (superiority); (2) death or BARC type 2 or higher bleeding (non-inferiority)