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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448642
First Posted: October 7, 2011
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital do Coracao
October 6, 2011
October 7, 2011
October 20, 2017
April 2012
November 2017   (Final data collection date for primary outcome measure)
Major Cardiovascular Events (MACE) [ Time Frame: 30 days ]
All-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary artery bypass grafting
Major Cardiovascular Events (MACE) [ Time Frame: 30 days ]
Complete list of historical versions of study NCT01448642 on ClinicalTrials.gov Archive Site
  • Major Cardiovascular Events (MACE) [ Time Frame: 6 months and 12 months ]
  • All-cause mortality [ Time Frame: 30 days, 6 months and 12 months ]
  • Non-fatal Myocardial Infarction [ Time Frame: 30 days, 6 months and 12 months ]
  • Non-fatal Stroke [ Time Frame: 30 days, 6 months and 12 months ]
  • Revascularization [ Time Frame: 30 days, 6 months and 12 months ]
  • Cardiovascular death [ Time Frame: 30 days, 6 months and 12 months ]
  • Stent Thrombosis [ Time Frame: 30 days, 6 months and 12 months ]
  • Target vessel revascularization [ Time Frame: 30 days, 6 months and 12 months ]
  • Rhabdomyolysis [ Time Frame: 7 days or at hospital discharge ]
  • Bleeding episode [ Time Frame: 7 days or hospital discharge ]
  • Cardiovascular Mortality [ Time Frame: 30 days ]
  • Revascularization of the Target Lesion [ Time Frame: 30 days ]
  • Peri-procedure Myocardial Infarction [ Time Frame: 30 days ]
  • Major Cardiovascular Events (MACE) [ Time Frame: 6 months ]
  • Major Cardiovascular Events (MACE) [ Time Frame: 12 months ]
  • Hepatotoxicity [ Time Frame: 30 days ]
  • Myopathy [ Time Frame: 30 days ]
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 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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • 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
  • 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.
 
Active, not recruiting
4192
November 2018
November 2017   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01448642
185/2011
Yes
Not Provided
Not Provided
Hospital do Coracao
Hospital do Coracao
Ministry of Health, Brazil
Study Chair: Otavio Berwanger Hospital do Coracao
Study Chair: Renato D Lopes, MD, PhD Brazilian Clinical Research Institute
Hospital do Coracao
January 2016

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