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Prasugrel monotherapy versus standard DAPT in STEMI patients with OCT-guided or angio-guided complete revascularisation: design and rationale of the randomised, multifactorial COMPARE STEMI ONE trial
V. Paradies, NM. Van Mieghem, RM. Oemrawsingh, G. Richardt, G. Esposito, G. Campo, F. Burzotta, P. Canova, A. Linke, I. Porto, D. Trabattoni, K. Teeuwen, T. Adriaenssens, P. Kala, G. Stankovic, RV. Vliet, D. Giacoppo, J. Daemen, PC. Smits
Language English Country France
Document type Journal Article, Clinical Trial Protocol, Randomized Controlled Trial, Multicenter Study, Comparative Study
- MeSH
- Purinergic P2Y Receptor Antagonists * therapeutic use MeSH
- ST Elevation Myocardial Infarction * therapy drug therapy diagnostic imaging surgery MeSH
- Platelet Aggregation Inhibitors * therapeutic use MeSH
- Coronary Angiography methods MeSH
- Percutaneous Coronary Intervention * methods MeSH
- Humans MeSH
- Tomography, Optical Coherence * methods MeSH
- Prasugrel Hydrochloride * therapeutic use MeSH
- Randomized Controlled Trials as Topic MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Clinical Trial Protocol MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
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
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 Maasstad Hospital Rotterdam the Netherlands
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
References provided by Crossref.org
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