• American heart journal · Apr 2018

    Randomized Controlled Trial Multicenter Study Comparative Study

    Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial.

    • Otavio Berwanger, Pedro G M de Barros E Silva, Frederico Toledo Campo Dall Orto, Pedro Beraldo de Andrade, de Castro BienertIgor RibeiroIRResearch Institute-Heart Hospital (HCor), Rua Abílio Soares 250, 12th floor, 04005-000, São Paulo, SP, Brazil., Carlos Eduardo Bosso, José Mangione, Carisi Anne Polanczyk, Amanda Sousa, Renato Kalil, de Moura SantosLucianoLResearch Institute-Heart Hospital (HCor), Rua Abílio Soares 250, 12th floor, 04005-000, São Paulo, SP, Brazil., Andrei C Sposito, Rafael L Rech, SousaAntonio Carlos SobralACSResearch Institute-Heart Hospital (HCor), Rua Abílio Soares 250, 12th floor, 04005-000, São Paulo, SP, Brazil., Felipe Baldissera, Bruno Ramos Nascimento, de Andrade JesuínoIsabellaIResearch Institute-Heart Hospital (HCor), Rua Abílio Soares 250, 12th floor, 04005-000, São Paulo, SP, Brazil., Eliana Vieira Santucci, Lucas Petri Damiani, Ligia N Laranjeira, Juliana A Borges de Oliveira, Roberto R Giraldez, Alexandre Biasi Cavalcanti, Sabrina Bernardez Pereira, Luiz Alberto Mattos, Luciana Vidal Armaganijan, Hélio Penna Guimarães, José Eduardo Sousa, John H Alexander, Christopher B Granger, and Renato D Lopes.
    • Research Institute-Heart Hospital (HCor), Rua Abílio Soares 250, 12th floor, 04005-000, São Paulo, SP, Brazil. Electronic address: oberwanger@hcor.com.br.
    • Am. Heart J. 2018 Apr 1; 198: 129-134.

    BackgroundPrevious evidence suggests that acute treatment with statins reduce atherosclerotic complications, including periprocedural myocardial infarction, but currently, there are no large, adequately powered studies to define the effects of early, high-dose statins in patients with acute coronary syndrome (ACS) and planned invasive management.ObjectivesThe main goal of Statins Evaluation in Coronary procedUres and REvascularization (SECURE-PCI) Trial is to determine whether the early use of a loading dose of 80 mg of atorvastatin before an intended percutaneous coronary intervention followed by an additional dose of 80 mg 24 hours after the procedure will be able to reduce the rates of major cardiovascular events at 30 days in patients with an ACS.DesignThe SECURE-PCI study is a pragmatic, multicenter, double-blind, placebo-controlled randomized trial planned to enroll around 4,200 patients in 58 different sites in Brazil. The primary outcome is the rate of major cardiovascular events at 30 days defined as a composite of all-cause mortality, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization.SummaryThe SECURE PCI is a large randomized trial testing a strategy of early, high-dose statin in patients with ACS and will provide important information about the acute treatment of this patient population.Copyright © 2018 Elsevier Inc. All rights reserved.

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