Clinical trial NCT01448642: Statins Evaluation in Coronary Procedures and Revascularization Trial
Official title: A Randomized, Multicenter Clinical Trial to Assess the Effect of Atorvastatin in Patients With Acute Coronary Syndrome and Intended Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2011-10-07
Enrollment: 4191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Major Cardiovascular Events (MACE)
timeFrame: 30 days
Secondary outcomes:
measure: Major Cardiovascular Events (MACE)
timeFrame: 6 months and 12 months
measure: All-cause mortality
timeFrame: 30 days, 6 months and 12 months
measure: Non-fatal Myocardial Infarction
timeFrame: 30 days, 6 months and 12 months
measure: Non-fatal Stroke
timeFrame: 30 days, 6 months and 12 months
measure: Revascularization
timeFrame: 30 days, 6 months and 12 months
measure: Cardiovascular death
timeFrame: 30 days, 6 months and 12 months
measure: Stent Thrombosis
timeFrame: 30 days, 6 months and 12 months
measure: Target vessel revascularization
timeFrame: 30 days, 6 months and 12 months
measure: Rhabdomyolysis
timeFrame: 7 days or at hospital discharge
measure: Bleeding episode
timeFrame: 7 days or hospital discharge
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital do Coracao
state: SP
Study officials:
affiliation: Hospital do Coracao
name: Otavio Berwanger
role: STUDY_CHAIR
affiliation: Brazilian Clinical Research Institute
name: Renato D Lopes, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.