Atorvastatin in Perioperative Vascular Surgery - Pilot Study

Vascular Surgery Clinical Trial

— APVS  

Official title:

Atorvastatin 80mg Versus Atorvastatin 20mg in Perioperative Vascular Surgery to Evaluate Cardiovascular Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610545
• Other study ID #: FCM-UNICAMP - 620/2006
• Secondary ID: 0492.0.146.000-0
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2008
• Last updated: February 13, 2009
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vascular Surgery

Intervention

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

Locations

Country	Name	City	State
Brazil	Clinics Hospital - State University Campinas	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality ; myocardial infarction ; stroke		within 90 days after surgery	Yes
Secondary	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	Yes
Secondary	Change and percent change from baseline to the surgery of treatment for hs-CRP		within 24h before surgery	Yes
Secondary	Safety of atorvastatin through laboratory assessment		within 24h before surgery	Yes