The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Coronary interventions
Prasugrel monotherapy after PCI with the SYNERGY stent in patients with chronic stable angina or stabilised acute coronary syndromes: rationale and design of the ASET pilot study
Norihiro Kogame1,2, MD; Rodrigo Modolo3, MD; Mariusz Tomaniak4,5, MD; Rafael Cavalcante6, MD, PhD; Fernando de Martino7, MD, PhD; Joao Tinoco8, MD; Expedito E. Ribeiro9, MD, PhD; Roxana Mehran10, MD; Carlos M. Campos9, MD, PhD; Yoshinobu Onuma4, MD, PhD; Pedro A. Lemos9, MD, PhD; Patrick W. Serruys11, MD, PhD
1. Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands; 2. Department of Cardiology, Toho University medical center Ohashi hospital, Tokyo, Japan; 3. Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil; 4. Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; 5. First Department of Cardiology, Subdivision of Interventional Cardiology, Medical University of Warsaw, Warsaw, Poland; 6. Boston Scientific, Marlborough, MA, USA; 7. Department of Internal Medicine, Discipline of Cardiology, University of Triangulo Mineiro, Uberaba, MG, Brazil; 8. Unicor, Linhares, ES, Brazil; 9. Heart Institute (InCor), University of Sao Paulo, Sao Paulo, Brazil; 10. Icahn School of Medicine at Mount Sinai, New York, NY, USA; 11. Imperial College London, London, United Kingdom
Introduction
The ASET (Acetyl Salicylic Elimination Trial) pilot study (NCT03469856) is designed to evaluate the hypothesis that a single antiplatelet therapy with prasugrel starting immediately after the procedure is feasible and safe in patients selected after successful percutaneous coronary intervention (PCI) with new-generation biodegradable polymer drug-eluting stent (DES) implantation.
Methods
STUDY DESIGN
The ASET pilot study is designed as a multicentre, single-arm, open-label, proof-of-concept pilot trial. Based on previous pilot studies with similar designs, a sample of 200 patients will be enrolled from 12 centres in Brazil with a stopping rule based on the occurrence of definite ...
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