Atorvastatin in Perioperative Vascular Surgery - Pilot Study

Condition(s) targeted: Vascular Surgery

Intervention: ATORVASTATIN (Drug); ATORVASTATIN (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Campinas, Brazil

Official(s) and/or principal investigator(s):
OTAVIO COELHO, PhD, Study Director, Affiliation: STATE UNIVERSITY CAMPINAS
RAITANY C ALMEIDA, MD, Principal Investigator, Affiliation: STATE UNIVERSITY CAMPINAS

Overall contact:
RAITANY C ALMEIDA, MD, Phone: 55-19-81117375, Email: raitany2001@yahoo.com.br

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment

Primary outcome: mortality ; myocardial infarction ; stroke

Secondary outcome:

Change and percent change from baseline to the surgery of treatment for LDL-C, HDL-C, TC, and TG for subjects

Change and percent change from baseline to the surgery of treatment for hs-CRP

Safety of atorvastatin through laboratory assessment

Minimum age: 40 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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

RAITANY C ALMEIDA, MD, Phone: 55-19-81117375, Email: raitany2001@yahoo.com.br

Clinics Hospital - State University Campinas, CAMPINAS, SÃO PAULO 13083970, Brazil; Recruiting
RAITANY C ALMEIDA, MD, Phone: 55-19-81117375, Email: raitany2001@yahoo.com.br
RAITANY C ALMEIDA, MD, Principal Investigator

Starting date: July 2007
Ending date: December 2008
Last updated: February 7, 2008