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

Hospital do Coracao

Status and phase

Completed

Phase 4

Conditions

Acute Coronary Syndrome

Treatments

Drug: Placebo

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01448642

185/2011

Details and patient eligibility

About

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).

Full 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.

Enrollment

4,191 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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