Atorvastatin in Perioperative Vascular Surgery - Pilot Study

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00610545

Acronym

APVS

Enrollment

100

Registered

2008-02-08

Start date

2007-07-31

Completion date

2008-12-31

Last updated

2009-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Surgery

Keywords

ATORVASTATIN, VASCULAR SURGERY, CARDIOVASCULAR OUTCOMES

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

Interventions

DRUGAtorvastatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
mortality ; myocardial infarction ; stroke	within 90 days after surgery

Secondary

Measure	Time frame
Safety of atorvastatin through laboratory assessment	within 24h before surgery
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026