A comparison of reduced-dose prasugrel and standard-dose clopidogrel in elderly patients with acute coronary syndromes undergoing early percutaneous revascularization: Design and rationale of the randomized Elderly-ACS 2 study

Luca A. Ferri, Nuccia Morici, Daniele Grosseto, Giovanni Tortorella, Irene Bossi, Paolo Sganzerla, Michele Cacucci, Girolamo Sibilio, Stefano Tondi, Anna Toso, Maurizio Ferrario, Nicola Gandolfo, Amelia Ravera, Matteo Mariani, Elena Corrada, Leonardo Di Ascenzo, Anna Sonia Petronio, Claudio Cavallini, Nadia Moffa, Stefano De ServiStefano Savonitto

Research output: Contribution to journalArticle

Abstract

Background Elderly patients display higher on clopidogrel platelet reactivity as compared with younger patients. Treatment with prasugrel 5 mg 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 75 mg in patients older than 74 years 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).

Original languageEnglish
Pages (from-to)101-106
Number of pages6
JournalAmerican Heart Journal
Volume181
DOIs
Publication statusPublished - Nov 1 2016

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clopidogrel
Acute Coronary Syndrome
Myocardial Infarction
Hemorrhage
Troponin
Percutaneous Coronary Intervention
Thoracic Surgery
Multicenter Studies
Prasugrel Hydrochloride
Creatinine
Electrocardiography
Therapeutics
Blood Platelets

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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A comparison of reduced-dose prasugrel and standard-dose clopidogrel in elderly patients with acute coronary syndromes undergoing early percutaneous revascularization : Design and rationale of the randomized Elderly-ACS 2 study. / Ferri, Luca A.; Morici, Nuccia; Grosseto, Daniele; Tortorella, Giovanni; Bossi, Irene; Sganzerla, Paolo; Cacucci, Michele; Sibilio, Girolamo; Tondi, Stefano; Toso, Anna; Ferrario, Maurizio; Gandolfo, Nicola; Ravera, Amelia; Mariani, Matteo; Corrada, Elena; Di Ascenzo, Leonardo; Petronio, Anna Sonia; Cavallini, Claudio; Moffa, Nadia; De Servi, Stefano; Savonitto, Stefano.

In: American Heart Journal, Vol. 181, 01.11.2016, p. 101-106.

Research output: Contribution to journalArticle

Ferri, LA, Morici, N, Grosseto, D, Tortorella, G, Bossi, I, Sganzerla, P, Cacucci, M, Sibilio, G, Tondi, S, Toso, A, Ferrario, M, Gandolfo, N, Ravera, A, Mariani, M, Corrada, E, Di Ascenzo, L, Petronio, AS, Cavallini, C, Moffa, N, De Servi, S & Savonitto, S 2016, 'A comparison of reduced-dose prasugrel and standard-dose clopidogrel in elderly patients with acute coronary syndromes undergoing early percutaneous revascularization: Design and rationale of the randomized Elderly-ACS 2 study', American Heart Journal, vol. 181, pp. 101-106. https://doi.org/10.1016/j.ahj.2016.08.010
Ferri, Luca A. ; Morici, Nuccia ; Grosseto, Daniele ; Tortorella, Giovanni ; Bossi, Irene ; Sganzerla, Paolo ; Cacucci, Michele ; Sibilio, Girolamo ; Tondi, Stefano ; Toso, Anna ; Ferrario, Maurizio ; Gandolfo, Nicola ; Ravera, Amelia ; Mariani, Matteo ; Corrada, Elena ; Di Ascenzo, Leonardo ; Petronio, Anna Sonia ; Cavallini, Claudio ; Moffa, Nadia ; De Servi, Stefano ; Savonitto, Stefano. / A comparison of reduced-dose prasugrel and standard-dose clopidogrel in elderly patients with acute coronary syndromes undergoing early percutaneous revascularization : Design and rationale of the randomized Elderly-ACS 2 study. In: American Heart Journal. 2016 ; Vol. 181. pp. 101-106.
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abstract = "Background Elderly patients display higher on clopidogrel platelet reactivity as compared with younger patients. Treatment with prasugrel 5 mg 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 75 mg in patients older than 74 years 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).",
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T2 - Design and rationale of the randomized Elderly-ACS 2 study

AU - Ferri, Luca A.

AU - Morici, Nuccia

AU - Grosseto, Daniele

AU - Tortorella, Giovanni

AU - Bossi, Irene

AU - Sganzerla, Paolo

AU - Cacucci, Michele

AU - Sibilio, Girolamo

AU - Tondi, Stefano

AU - Toso, Anna

AU - Ferrario, Maurizio

AU - Gandolfo, Nicola

AU - Ravera, Amelia

AU - Mariani, Matteo

AU - Corrada, Elena

AU - Di Ascenzo, Leonardo

AU - Petronio, Anna Sonia

AU - Cavallini, Claudio

AU - Moffa, Nadia

AU - De Servi, Stefano

AU - Savonitto, Stefano

PY - 2016/11/1

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N2 - Background Elderly patients display higher on clopidogrel platelet reactivity as compared with younger patients. Treatment with prasugrel 5 mg 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 75 mg in patients older than 74 years 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).

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