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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hospital do Coracao
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01448642
First received: October 6, 2011
Last updated: February 24, 2014
Last verified: February 2014

October 6, 2011
February 24, 2014
April 2012
November 2014   (final data collection date for primary outcome measure)
Major Cardiovascular Events (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
All-cause mortality, nonfatal acute myocardial infarction, stroke or recurrent ischemia leading to urgent revascularization
Major Cardiovascular Events (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01448642 on ClinicalTrials.gov Archive Site
  • Cardiovascular Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Revascularization of the Target Lesion [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Non-fatal Myocardial Infarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Major Cardiovascular Events (MACE) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Major Cardiovascular Events (MACE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stent Thrombosis [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Stent Thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Stent Thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Revascularization of the Target Lesion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Revascularization of the Target Lesion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rhabdomyolysis [ Time Frame: 7 days or at hospital discharge ] [ Designated as safety issue: No ]
  • Bleeding episode [ Time Frame: 7 days or hospital discharge ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Recurrent ischemia leading to urgent revascularization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cardiovascular Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Revascularization of the Target Lesion [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Peri-procedure Myocardial Infarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Major Cardiovascular Events (MACE) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Major Cardiovascular Events (MACE) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Hepatotoxicity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Myopathy [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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 recurrent ischemia leading to urgent revascularization 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Atorvastatin
    Atorvastatin loading dose of 80mg before PCI, reloading dose of 80mg 12 hours after PCI, and atorvastatin 40mg for 30 days
    Other Name: Atorvastatin
  • Drug: Placebo
    Matching placebo before PCI and 12 hours after PCI. Atorvastatin 40mg for 30 days
    Other Name: Placebo
  • Active Comparator: Atorvastatin
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4192
November 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Otavio Berwanger, MD,PhD +55 11 30536611 ext 8201 oberwanger@hcor.com.br
Brazil
 
NCT01448642
185/2011
Yes
Hospital do Coracao
Hospital do Coracao
Ministry of Health, Brazil
Study Chair: Jose Eduardo Sousa, MD, PhD Hospital do Coracao
Study Chair: Renato D Lopes, MD, PhD Brazilian Clinical Research Institute
Hospital do Coracao
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP