Atorvastatin in Perioperative Vascular Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Vascular Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

2

Use Atorvastatin 20 mg for 60 days , and the vascular surgery will be made between day-7 and day-60

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

Interventions

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Atorvastatin

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

Intervention Type DRUG

Atorvastatin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No