Monotherapy with a potent P2Y12 receptor antagonist after 1 month of dual antiplatelet therapy (DAPT) may reduce bleeding in the absence of increased ischaemic events compared to 12-month DAPT in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). PCI guidance with optical coherence tomography (OCT) may enhance stent expansion. COMPARE STEMI ONE is an international, multicentre, open-label, randomised controlled trial. In 1,656 ST-segment elevation myocardial infarction (STEMI) patients, prasugrel monotherapy after 1 month of DAPT, as compared to standard 12-month prasugrel-based DAPT, will be tested for non-inferiority for the primary composite endpoint of net adverse clinical events - defined as all-cause death, myocardial infarction, stroke, or Bleeding Academic Research Consortium Type 3 or 5 bleeding events - at 11 months after randomisation. Furthermore, an ancillary substudy will test the superiority of OCT-guided versus angiography-guided staged complete revascularisation in achieving a larger minimal stent area (MSA) in non-culprit lesions during staged procedures. COMPARE STEMI ONE is the first randomised controlled trial assessing an abbreviated 1-month DAPT regimen followed by prasugrel monotherapy in the context of STEMI. The trial will also study the value of OCT-guided PCI in terms of the MSA of non-culprit lesions and may elucidate potential synergies between intravascular imaging-guided PCI and abbreviated DAPT regimens. (ClinicalTrials.gov: NCT05491200).

Cardiology Department Catharina Hospital Eindhoven the Netherlands

Cardiology Department Heart Center Dresden University Dresden Germany

Cardiology Unit Azienda Ospedaliero Univesitaria di Ferrara Cona Italy

Cardiovascular Disease Unit IRCCS Ospedale Policlinico San Martino Genoa Italy

Cardiovascular Research Institute Mater Private Hospital Royal College of Surgeons in Ireland Dublin Ireland

Department of Advanced Biomedical Sciences University of Naples Federico 2 Naples Italy

Department of Cardiology Amphia Hospital Breda the Netherlands

Department of Cardiology Asklepios Klinik Bad Oldesloe Bad Oldesloe Germany

Department of Cardiology Cardiovascular Institute Thoraxcenter Erasmus University Medical Center Rotterdam the Netherlands

Department of Cardiology Maasstad Hospital Rotterdam the Netherlands

Department of Cardiology University Clinical Center of Serbia Belgrade Serbia and Faculty of Medicine University of Belgrade Belgrade Serbia

Department of Cardiovascular Medicine University Hospitals Leuven Leuven Belgium and Department of Cardiovascular Sciences Katholieke Universiteit Leuven Leuven Belgium

Department of General Surgery and Surgical Medical Specialties University of Catania Catania Italy

Department of Interventional Cardiology Centro Cardiologico Monzino IRCCS Milan Italy

Fondazione Policlinico Universitario A Gemelli IRCCS Università Cattolica del Sacro Cuore Rome Italy

ISAResearch Zentrum German Heart Center Munich Germany

Ospedale Papa Giovanni XXIII Bergamo Italy

The University Hospital Brno Medical Faculty of Masaryk University Brno Czech Republic

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ClinicalTrials.gov
NCT05491200