Trial | NCT01448642  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    atorvastatin ...

  • Study Participants

    4191
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).
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 Started
Apr 30
2012
Primary Completion
Nov 30
2017
Study Completion
Apr 30
2018
Last Update
Jun 17
2019

Drug Atorvastatin

Atorvastatin loading dose of 80mg before PCI, reloading dose of 80mg 24 hours after PCI, and atorvastatin 40mg for 30 days

Drug Placebo

Matching placebo before PCI and 24 hours after PCI. Atorvastatin 40mg for 30 days

Atorvastatin Active Comparator

Placebo Placebo Comparator

Criteria 

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
No Results Posted