BACKGROUND: Previous 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. OBJECTIVES: The 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. DESIGN: The 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. SUMMARY: The 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.
RCT Entities:
BACKGROUND: Previous 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. OBJECTIVES: The 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. DESIGN: The 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. SUMMARY: The 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.
Authors: Renato D Lopes; Pedro G M de Barros E Silva; Isabella de Andrade Jesuíno; Eliana Vieira Santucci; Lilian Mazza Barbosa; Lucas Petri Damiani; Renato Hideo Nakagawa Santos; Ligia Nasi Laranjeira; Frederico Toledo Campo Dall Orto; Pedro Beraldo de Andrade; Igor Ribeiro de Castro Bienert; John H Alexander; Christopher B Granger; Otavio Berwanger Journal: JAMA Cardiol Date: 2018-11-01 Impact factor: 14.676
Authors: Otavio Berwanger; Eliana Vieira Santucci; Pedro Gabriel Melo de Barros E Silva; Isabella de Andrade Jesuíno; Lucas Petri Damiani; Lilian Mazza Barbosa; Renato Hideo Nakagawa Santos; Ligia Nasi Laranjeira; Flávia de Mattos Egydio; Juliana Aparecida Borges de Oliveira; Frederico Toledo Campo Dall Orto; Pedro Beraldo de Andrade; Igor Ribeiro de Castro Bienert; Carlos Eduardo Bosso; José Armando Mangione; Carisi Anne Polanczyk; Amanda Guerra de Moraes Rego Sousa; Renato Abdala Karam Kalil; Luciano de Moura Santos; Andrei Carvalho Sposito; Rafael Luiz Rech; Antônio Carlos Sobral Sousa; Felipe Baldissera; Bruno Ramos Nascimento; Roberto Rocha Corrêa Veiga Giraldez; Alexandre Biasi Cavalcanti; Sabrina Bernardez Pereira; Luiz Alberto Mattos; Luciana Vidal Armaganijan; Hélio Penna Guimarães; José Eduardo Moraes Rego Sousa; John Hunter Alexander; Christopher Bull Granger; Renato Delascio Lopes Journal: JAMA Date: 2018-04-03 Impact factor: 56.272