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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 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: January 19, 2016
Last verified: January 2016
  Purpose
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 Intervention Phase
Acute Coronary Syndrome
Drug: Atorvastatin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • Major Cardiovascular Events (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    All-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4192
Study Start Date: April 2012
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448642

Contacts
Contact: Otavio Berwanger, MD,PhD +55 11 30536611 ext 8201 oberwanger@hcor.com.br

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

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01448642     History of Changes
Other Study ID Numbers: 185/2011 
Study First Received: October 6, 2011
Last Updated: January 19, 2016
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 25, 2016