Statins Evaluation in Coronary Procedures and Revascularization Trial

Acute Coronary Syndrome Clinical Trial

— SECURE-PCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448642
• Other study ID #: 185/2011
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: April 2018

Study information

• Verified date: June 2019
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4191
• Est. completion date: April 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Atorvastatin
Atorvastatin loading dose of 80mg before PCI, reloading dose of 80mg 24 hours after PCI, and atorvastatin 40mg for 30 days
• Placebo
Matching placebo before PCI and 24 hours after PCI. Atorvastatin 40mg for 30 days

Locations

Country	Name	City	State
Brazil	Hospital do Coracao	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Berwanger O, Santucci EV, de Barros E Silva PGM, Jesuíno 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, — View Citation

Outcome

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