Atorvastatin in Perioperative Vascular Surgery - Pilot Study

Phase 4

Completed

• Conditions: Vascular Surgery
• Interventions: Drug: Atorvastatin

• Registration Number: NCT00610545
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-08
• Primary Completion: 2008-09
• Study Completion: 2008-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-13
• Last Update Posted: 2009-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Atorvastatin	Use Atorvastatin 80mg for 60 days , and the vascular surgery will be made between day-7 and day-60
2	Atorvastatin	Use Atorvastatin 20 mg for 60 days , and the vascular surgery will be made between day-7 and day-60

Primary Outcome Measures

Name	Time	Method
mortality ; myocardial infarction ; stroke	within 90 days after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinics Hospital - State University Campinas; 🇧🇷 Campinas, São Paulo, Brazil