Atorvastatin in Perioperative Vascular Surgery - Pilot Study

Study Overview
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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

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

Conditions
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Vascular Surgery

Intervention / Treatment
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* Drug: Atorvastatin
* Drug: Atorvastatin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Use Atorvastatin 80mg for 60 days , and the vascular surgery will be made between day-7 and day-60 | Drug: Atorvastatin<br>* Atorvastatin 80 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60<br>|
| Active Comparator: 2<br>Use Atorvastatin 20 mg for 60 days , and the vascular surgery will be made between day-7 and day-60 | Drug: Atorvastatin<br>* Atorvastatin 20 mg; Use Atorvastatin for 60 days , and the vascular surgery will be made between day-7 and day-60<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality ; myocardial infarction ; stroke |  | within 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Safety of atorvastatin through laboratory assessment |  | within 24h before surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ATORVASTATIN, VASCULAR SURGERY, CARDIOVASCULAR OUTCOMES