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

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ClinicalTrials.gov Identifier: NCT01448642
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital do Coracao

Study Description
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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).

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Atorvastatin Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter Clinical Trial to Assess the Effect of Atorvastatin in Patients With Acute Coronary Syndrome and Intended Percutaneous Coronary Intervention
Actual Study Start Date : April 2012
Actual Primary Completion Date : November 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Atorvastatin Drug: Atorvastatin
Atorvastatin loading dose of 80mg before PCI, reloading dose of 80mg 24 hours after PCI, and atorvastatin 40mg for 30 days
Placebo Comparator: Placebo Drug: Placebo
Matching placebo before PCI and 24 hours after PCI. Atorvastatin 40mg for 30 days


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Major Cardiovascular Events (MACE) [ Time Frame: 6 months and 12 months ]
  2. All-cause mortality [ Time Frame: 30 days, 6 months and 12 months ]
  3. Non-fatal Myocardial Infarction [ Time Frame: 30 days, 6 months and 12 months ]
  4. Non-fatal Stroke [ Time Frame: 30 days, 6 months and 12 months ]
  5. Revascularization [ Time Frame: 30 days, 6 months and 12 months ]
  6. Cardiovascular death [ Time Frame: 30 days, 6 months and 12 months ]
  7. Stent Thrombosis [ Time Frame: 30 days, 6 months and 12 months ]
  8. Target vessel revascularization [ Time Frame: 30 days, 6 months and 12 months ]
  9. Rhabdomyolysis [ Time Frame: 7 days or at hospital discharge ]
  10. Bleeding episode [ Time Frame: 7 days or hospital discharge ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448642


Locations
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Brazil
Hospital do Coracao
Sao Paulo, SP, Brazil, 04005-000
Sponsors and Collaborators
Hospital do Coracao
Ministry of Health, Brazil
Investigators
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Study Chair: Otavio Berwanger Hospital do Coracao
Study Chair: Renato D Lopes, MD, PhD Brazilian Clinical Research Institute
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01448642    
Other Study ID Numbers: 185/2011
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors