Official Title: “Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes”

This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce cardiovascular outcomes ( mortality - myocardial infarction - stroke ) when given in high doses in comparative standard doses in the perioperative period of major vascular surgery.

Abdominal aortic aneurysm , Carotid endarterectomy , Revascularization of lower limbs

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Dose Comparison, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin
  • Atorvastatin 80 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60
• Drug: Atorvastatin
  • Atorvastatin 20 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Use Atorvastatin 80mg for 60 days , and the vascular surgery will be made between day-7 and day-60
• Active Comparator: 2
  • Use Atorvastatin 20 mg for 60 days , and the vascular surgery will be made between day-7 and day-60

Primary Measures

• mortality ; myocardial infarction ; stroke
  • Time Frame: within 90 days after surgery
    Safety Issue?: Yes

Secondary Measures

• Change and percent change from baseline to the surgery of treatment for LDL-C, HDL-C, TC, and TG for subjects
  • Time Frame: within 24h before surgery
    Safety Issue?: Yes
• Change and percent change from baseline to the surgery of treatment for hs-CRP
  • Time Frame: within 24h before surgery
    Safety Issue?: Yes
• Safety of atorvastatin through laboratory assessment
  • Time Frame: within 24h before surgery
    Safety Issue?: Yes

Inclusion Criteria:

• Vascular surgery (abdominal aortic aneurysm , carotid endarterectomy , limbs revascularization)

Exclusion Criteria:

• Pregnant or lactating women
• Patient with sensitivity to atorvastatin
• Patient has elevations in certain laboratory values (CK, AST, ALT)
• Known history of active hepatic disease or known hepatic insufficiency
• Patients participating in another clinical trial
• Prior statin therapy to include: >10 mg of atorvastatin (Lipitor) or >20 mg of other
• HMG-CoA Reductase Inhibitors (statins) or use rosuvastatin
• Serious infectious disease after surgery
• Known history of cancer

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Campinas, Brazil

Overall Clinical Trial Officials and Contacts

OTAVIO COELHO, PhD Study Director STATE UNIVERSITY CAMPINAS  

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00610545

Study ID Number: FCM-UNICAMP - 620/2006

ClinicalTrials.gov Identifier: NCT00610545

Health Authority: Brazil: National Committee of Ethics in Research