Luca A Ferri1, Nuccia Morici2, Daniele Grosseto3, Giovanni Tortorella4, Irene Bossi2, Paolo Sganzerla5, Michele Cacucci6, Girolamo Sibilio7, Stefano Tondi8, Anna Toso9, Maurizio Ferrario10, Nicola Gandolfo11, Amelia Ravera12, Matteo Mariani13, Elena Corrada14, Leonardo Di Ascenzo15, Anna Sonia Petronio16, Claudio Cavallini17, Nadia Moffa18, Stefano De Servi19, Stefano Savonitto20. 1. Division of Cardiology, Ospedale Manzoni, Lecco, Italy. 2. First Division of Cardiology-Interventional Cardiology, Ospedale Niguarda, Milan, Italy. 3. Division of Cardiology, Ospedale Infermi, Rimini, Italy. 4. Division of Cardiology, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy. 5. Division of Cardiology, Ospedale Treviglio-Caravaggio, Treviglio, Italy. 6. Division of Cardiology, Ospedale Maggiore, Crema, Italy. 7. Division of Cardiology, Ospedale S. Maria delle Grazie, Pozzuoli, Italy. 8. Division of Cardiology, Ospedale Baggiovara, Modena, Italy. 9. Division of Cardiology, Ospedale S. Stefano, Prato, Italy. 10. IRCCS Fondazione Policlinico S. Matteo, Division of Cardiology, Pavia, Italy. 11. Division of Cardiology, Ospedale Mauriziano, Torino, Italy. 12. Division of Cardiology, Ospedale Ruggi D' Aragona, Salerno, Italy. 13. Division of Cardiology, Ospedale Civile, Legnano, Italy. 14. Cardiovascular Department, Humanitas Clinical and Research Center, Rozzano, Italy. 15. Ospedale di Portogruaro, Division of Cardiology, Portogruaro, Italy. 16. Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria Pisana, Cardiac Catheterization Laboratory, Pisa, Italy. 17. Division of Cardiology, Ospedale S. Maria della Misericordia, Perugia, Italy. 18. Mediolanum Cardio Research, Milan, Italy. 19. Cardiovascular Department IRCCS Multimedica, Sesto San Giovanni, Italy. 20. Division of Cardiology, Ospedale Manzoni, Lecco, Italy. Electronic address: s.savonitto@asst-lecco.it.
Abstract
BACKGROUND: Elderly patients display higher on clopidogrel platelet reactivity as compared with younger patients. Treatment with prasugrel 5mg has been shown to provide more predictable and homogenous antiplatelet effect, as compared with clopidogrel, suggesting the possibility of reducing ischemic events after an acute coronary syndrome (ACS) without increasing bleeding. STUDY DESIGN: The Elderly-ACS 2 study is a multicenter, randomized, parallel-group, open-label trial designed to demonstrate the superiority of a strategy of dual antiplatelet treatment using a reduced 5-mg daily dose of prasugrel over a standard strategy with a daily clopidogrel dose of 75mg in patients older than 74years with ACS (either ST- or non-ST-elevation myocardial infarction) undergoing early percutaneous revascularization. The primary end point is the composite of all-cause mortality, myocardial reinfarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. Taking advantage of the planned size of 2,000 patients, the secondary objective is to assess the prognostic impact of selected prerandomization variables (age, sex, diabetic status, serum creatinine level, electrocardiogram changes, abnormal troponin levels, basal and residual SYNergybetween percutaneous coronary intervention with TAXus and cardiac surgery [SYNTAX] score). CONCLUSION: The Elderly-ACS 2 study is a multicenter, randomized trial comparing a strategy of dual antiplatelet therapy with a reduced dose of prasugrel with a standard dose of clopidogrel in elderly patients with ACS undergoing percutaneous revascularization (the Elderly ACS 2 trial: NCT01777503).
RCT Entities:
BACKGROUND: Elderly patients display higher on clopidogrel platelet reactivity as compared with younger patients. Treatment with prasugrel 5mg has been shown to provide more predictable and homogenous antiplatelet effect, as compared with clopidogrel, suggesting the possibility of reducing ischemic events after an acute coronary syndrome (ACS) without increasing bleeding. STUDY DESIGN: The Elderly-ACS 2 study is a multicenter, randomized, parallel-group, open-label trial designed to demonstrate the superiority of a strategy of dual antiplatelet treatment using a reduced 5-mg daily dose of prasugrel over a standard strategy with a daily clopidogrel dose of 75mg in patients older than 74years with ACS (either ST- or non-ST-elevation myocardial infarction) undergoing early percutaneous revascularization. The primary end point is the composite of all-cause mortality, myocardial reinfarction, disabling stroke, and rehospitalization for cardiovascular causes or bleeding within 1 year. Taking advantage of the planned size of 2,000 patients, the secondary objective is to assess the prognostic impact of selected prerandomization variables (age, sex, diabetic status, serum creatinine level, electrocardiogram changes, abnormal troponin levels, basal and residual SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery [SYNTAX] score). CONCLUSION: The Elderly-ACS 2 study is a multicenter, randomized trial comparing a strategy of dual antiplatelet therapy with a reduced dose of prasugrel with a standard dose of clopidogrel in elderly patients with ACS undergoing percutaneous revascularization (the Elderly ACS 2 trial: NCT01777503).
Authors: Gabriele Crimi; Nuccia Morici; Maurizio Ferrario; Luca A Ferri; Luigi Piatti; Daniele Grosseto; Michele Cacucci; Alessandro Mandurino Mirizzi; Anna Toso; Federico Piscione; Marco De Carlo; Luigi Raffaele Elia; Bruno Trimarco; Leonardo Bolognese; Francesco M Bovenzi; Giuseppe De Luca; Stefano Savonitto; Stefano De Servi Journal: J Am Heart Assoc Date: 2019-01-22 Impact factor: 5.501