Statins Evaluation in Coronary Procedures and Revascularization Trial (SECURE-PCI)

A Randomized, Multicenter Clinical Trial to Assess the Effect of Atorvastatin in Patients With Acute Coronary Syndrome and Intended Percutaneous Coronary Intervention

The purpose of this study is to determine whether a loading dose of atorvastatin before percutaneous intervention procedures in acute coronary syndromes is effective to reduce major cardiovascular events(MACE).

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Atorvastatin; Drug: Placebo

Detailed Description

Background: Strategies to reduce complications in acute coronary syndrome treatment have been largely studied. Due to its pleiotropic effects statins are considered an important tool on atherosclerotic plaque stability. Although, the usage of statins before percutaneous coronary intervention in acute coronary syndrome patients, has not yet been demonstrated. Objectives: Evaluate if a loading dose of atorvastatin (80mg) before percutaneous coronary intervention in acute coronary syndrome patients, followed by a reload dose 24 hours, is able to reduce major cardiovascular events (MACE); including combined outcomes such as all-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting after 30 days. Methods: Multicentric randomised controlled clinical trial, with allocation concealment and intention to treat analysis. Competitive recruitment will involve 4,192 patients. Acute coronary syndrome patients intending to undergo percutaneous coronary intervention with or without stent placement will be randomized 1:1 to receive either atorvastatin 80mg or placebo before the coronary procedure and also a reload dosage after 24 hours from angioplasty. All patients will collect blood sample to determine CKMB levels pre and post procedure (6 to 12h and 18 to 24 hours). After 30 days, an in person interview will be performed and blood sample will be collected in order to dosage AST, ALT, CPK, and cholesterol levels. Telephonic interview will be done at 6 and 12 months to access occurrence of cardiovascular events.

• Study Type: Interventional
• Enrollment (Actual): 4191
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04005-000
      • Hospital do Coracao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Acute coronary syndrome patients intending to undergo percutaneous coronary intervention.

Exclusion Criteria:

• Younger than 18 years
• Presence of any contraindication to statin (Pregnant women, breast-feeding women or statin hypersensibility)
• Advanced hepatic disease
• Use of statins at the maximum dosage in the last 24 hours before the loading dose of the study drug
• Use of fibrate in the last 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo before PCI and 24 hours after PCI. Atorvastatin 40mg for 30 days
Active Comparator: Atorvastatin	Drug: Atorvastatin; Atorvastatin loading dose of 80mg before PCI, reloading dose of 80mg 24 hours after PCI, and atorvastatin 40mg for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Cardiovascular Events (MACE)	All-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary artery bypass grafting	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Major Cardiovascular Events (MACE)	6 months and 12 months
All-cause mortality	30 days, 6 months and 12 months
Non-fatal Myocardial Infarction	30 days, 6 months and 12 months
Non-fatal Stroke	30 days, 6 months and 12 months
Revascularization	30 days, 6 months and 12 months
Cardiovascular death	30 days, 6 months and 12 months
Stent Thrombosis	30 days, 6 months and 12 months
Target vessel revascularization	30 days, 6 months and 12 months
Rhabdomyolysis	7 days or at hospital discharge
Bleeding episode	7 days or hospital discharge

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Collaborators: Ministry of Health, Brazil
• Investigators: Study Chair: Otavio Berwanger, Hospital do Coracao; Study Chair: Renato D Lopes, MD, PhD, Brazilian Clinical Research Institute

Publications and helpful links

General Publications

• Berwanger O, Santucci EV, de Barros E Silva PGM, Jesuino IA, Damiani LP, Barbosa LM, Santos RHN, Laranjeira LN, Egydio FM, Borges de Oliveira JA, Dall Orto FTC, Beraldo de Andrade P, Bienert IRC, Bosso CE, Mangione JA, Polanczyk CA, Sousa AGMR, Kalil RAK, Santos LM, Sposito AC, Rech RL, Sousa ACS, Baldissera F, Nascimento BR, Giraldez RRCV, Cavalcanti AB, Pereira SB, Mattos LA, Armaganijan LV, Guimaraes HP, Sousa JEMR, Alexander JH, Granger CB, Lopes RD; SECURE-PCI Investigators. Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial. JAMA. 2018 Apr 3;319(13):1331-1340. doi: 10.1001/jama.2018.2444. Erratum In: JAMA. 2018 Sep 4;320(9):938.
• Lopes RD, de Barros E Silva PGM, de Andrade Jesuino I, Santucci EV, Barbosa LM, Damiani LP, Nakagawa Santos RH, Laranjeira LN, Dall Orto FTC, Beraldo de Andrade P, de Castro Bienert IR, Alexander JH, Granger CB, Berwanger O. Timing of Loading Dose of Atorvastatin in Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes: Insights From the SECURE-PCI Randomized Clinical Trial. JAMA Cardiol. 2018 Nov 1;3(11):1113-1118. doi: 10.1001/jamacardio.2018.3408. Erratum In: JAMA Cardiol. 2018 Nov 1;3(11):1131.
• Berwanger O, de Barros E Silva PGM, Dall Orto FTC, de Andrade PB, de Castro Bienert IR, Bosso CE, Mangione J, Polanczyk CA, Sousa A, Kalil R, de Moura Santos L, Sposito AC, Rech RL, Sousa ACS, Baldissera F, Nascimento BR, de Andrade Jesuino I, Santucci EV, Damiani LP, Laranjeira LN, Borges de Oliveira JA, Giraldez RR, Cavalcanti AB, Pereira SB, Mattos LA, Armaganijan LV, Guimaraes HP, Sousa JE, Alexander JH, Granger CB, Lopes RD. Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial. Am Heart J. 2018 Apr;198:129-134. doi: 10.1016/j.ahj.2017.12.018. Epub 2018 Jan 8.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 14, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 185/2011