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.
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.


METHODS
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).


CONCLUSIONS
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).
Division of Cardiology, Ospedale Manzoni, Lecco, Italy.
Luca A
LA
Ferri
First Division of Cardiology-Interventional Cardiology, Ospedale Niguarda, Milan, Italy.
Nuccia
N
Morici
Division of Cardiology, Ospedale Infermi, Rimini, Italy.
Daniele
D
Grosseto
Division of Cardiology, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy.
Giovanni
G
Tortorella
First Division of Cardiology-Interventional Cardiology, Ospedale Niguarda, Milan, Italy.
Irene
I
Bossi
Division of Cardiology, Ospedale Treviglio-Caravaggio, Treviglio, Italy.
Paolo
P
Sganzerla
Division of Cardiology, Ospedale Maggiore, Crema, Italy.
Michele
M
Cacucci
Division of Cardiology, Ospedale S. Maria delle Grazie, Pozzuoli, Italy.
Girolamo
G
Sibilio
Division of Cardiology, Ospedale Baggiovara, Modena, Italy.
Stefano
S
Tondi
Division of Cardiology, Ospedale S. Stefano, Prato, Italy.
Anna
A
Toso
IRCCS Fondazione Policlinico S. Matteo, Division of Cardiology, Pavia, Italy.
Maurizio
M
Ferrario
Division of Cardiology, Ospedale Mauriziano, Torino, Italy.
Nicola
N
Gandolfo
Division of Cardiology, Ospedale Ruggi D' Aragona, Salerno, Italy.
Amelia
A
Ravera
Division of Cardiology, Ospedale Civile, Legnano, Italy.
Matteo
M
Mariani
Cardiovascular Department, Humanitas Clinical and Research Center, Rozzano, Italy.
Elena
E
Corrada
Ospedale di Portogruaro, Division of Cardiology, Portogruaro, Italy.
Leonardo
L
Di Ascenzo
Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria Pisana, Cardiac Catheterization Laboratory, Pisa, Italy.
Anna Sonia
AS
Petronio
Division of Cardiology, Ospedale S. Maria della Misericordia, Perugia, Italy.
Claudio
C
Cavallini
Mediolanum Cardio Research, Milan, Italy.
Nadia
N
Moffa
Cardiovascular Department IRCCS Multimedica, Sesto San Giovanni, Italy.
Stefano
S
De Servi
Division of Cardiology, Ospedale Manzoni, Lecco, Italy. Electronic address: s.savonitto@asst-lecco.it.
Stefano
S
Savonitto
D054058:Acute Coronary Syndrome / Q000628:therapy*; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use*; D002423:Cause of Death; D000077144:Clopidogrel; D004359:Drug Therapy, Combination; D061345:Early Medical Intervention; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D008297:Male; D009026:Mortality; D009203:Myocardial Infarction / Q000453:epidemiology / Q000628:therapy*; D010359:Patient Readmission; D062645:Percutaneous Coronary Intervention; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D000068799:Prasugrel Hydrochloride / Q000008:administration & dosage*; D058921:Purinergic P2Y Receptor Antagonists / Q000627:therapeutic use*; D012008:Recurrence; D020521:Stroke / Q000453:epidemiology; D013988:Ticlopidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D000077144:Clopidogrel; D000068799:Prasugrel Hydrochloride; D013988:Ticlopidine; D001241:Aspirin