Anti-inflammatory Effect of Atorvastatin in Atherosclerotic Plaques Assessed by FDG-PET Imaging

Study Overview
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Brief Summary
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The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG) PET.

Official Title
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Effect of Atorvastatin on Inflammatory Atherosclerotic Plaques Assessed by FDG-PET Imaging

Conditions
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Atherosclerosis, Inflammation

Intervention / Treatment
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* Drug: Atorvastatin
* Behavioral: Lifestyle counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with accumulation of FDG-PET in carotid artery or aorta Exclusion Criteria: LDL cholesterol level (calculated by using Friedewald formula) higher than 180 mg/dl or less than 120 mg/dl subjects currently taking HMG CoA-reductase (Statins) or fibrates symptomatic coronary artery diseases symptomatic cerebrovascular diseases subjects suffered from myocardial infarction or stroke within 6 months subjects underwent percutaneous vascular interventions or vascular operations within 6 months diabetic patients with poor glycemic control (HbA1c>8.5) hypertensive patients with poor blood pressure control subjects with neoplasms subjects with systemic inflammatory diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin<br> | Drug: Atorvastatin<br>* Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. The subjects are administered with 10mg/day for 3 months, if LDL-cholesterol levels does not decrease less than 80mg/dl, the dose is increased up to 20mg/day. If LDL-cholesterol levels decrease less than 60mg/dl, the dose is decreased down to 5mg/day or less.<br>* Other names: Lipitor;|
| Placebo Comparator: Lifestyle counseling<br>Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study. | Behavioral: Lifestyle counseling<br>* Subjects are advised to keep dietary habits according to the National Cholesterol Education Program (NCEP) from the run-in period throughout the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques |  | Baseline and 3 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow-mediated vasodilation of brachial artery determined by ultrasonography |  | Baseline and 3 months after intervention | 
| Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1 |  | Baseline and 3 months after intervention | 
| Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine |  | Baseline and 3 months after intervention | 
| Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography |  | Baseline and 3 months after intervention | 
| Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides |  | Baseline and 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atherosclerotic plaques, hypercholesterolemia, HMG-CoA reductase inhibitor, statin, lipid-lowering therapy