Statins Evaluation in Coronary Procedures and Revascularization Trial

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Placebo; Drug: Atorvastatin

• Registration Number: NCT01448642
• Lead Sponsor: Hospital do Coracao

Brief Summary

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).

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 Timeline

• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Study Start: 2012-04
• Primary Completion: 2017-11
• Study Completion: 2018-04
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-14
• Last Update Posted: 2019-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4191

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Atorvastatin	Atorvastatin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital do Coracao; 🇧🇷 Sao Paulo, SP, Brazil