Atorvastatin in Perioperative Vascular Surgery - Pilot Study (APVS)

University of Campinas, Brazil

Status and phase

Completed

Phase 4

Conditions

Vascular Surgery

Treatments

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00610545

FCM-UNICAMP - 620/2006

0492.0.146.000-06

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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