The Effect of Atorvastatin and Pioglitazone on Carotid Atherosclerosis With the Use of Positron Emission Tomography-computed Tomography (PET-CT)

Study Overview
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Brief Summary
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This study is a prospective randomized clinical trial and to compare the antiinflammatory effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy in carotid arteries of stable and unstable angina patients by PET/CT.

Official Title
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Evaluation of the Effect of Atorvastatin and Pioglitazone in Carotid Atherosclerosis With the Use of 18Fluoride-Fludeoxyglucose(FDG) Positron Emission Tomography-computed Tomography (PET-CT)Imaging

Conditions
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Atherosclerosis, Coronary Artery Disease

Intervention / Treatment
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* Drug: Atorvastatin 20mg
* Drug: Atorvastatin 20 mg + Pioglitazone 30 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject who has undergone percutaneous coronary intervention due to coronary artery disease ( stable angina or unstable angina) The subject described above who has atherosclerotic plaque in his/her carotid artery by carotid ultrasonography The subject who or a legal representative agrees to the clinical trial and gives written permission to the IRB-approved form. Exclusion Criteria: The subjets who have taken statins or thiazolidinedione with 4 weeks Marked elevated liver enzyme ( more than 2.5 fold compared to reference range) Renal insufficiency patients ( serum creatinine more than 2 mg/dl) Congestive heart failure ( NYHA class 2-4) Acue myocardial infarction Unstable angina with ST segment deviation Pregnancy The subjects enrolled in another studies

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin 20 mg<br>After the subject take PET CT, he or she is randomized to either  Atorvastatin 20 mg group or  Atorvastatin 20 mg+ Pioglitazone 30 mg. The  Atorvastatin 20 mg group is to take atorvastatin 20 mg and take follow up PET CT in 3 months | Drug: Atorvastatin 20mg<br>* 20 mg QD for 3 months<br>* Other names: Lipitor 20mg;|
| Experimental: Atorvastatin 20 mg + Pioglitazone 30 mg<br>After the subject take PET CT, he or she is randomized to either  Atorvastatin 20 mg group or  Atorvastatin 20 mg+ Pioglitazone 30 mg. The  Atorvastatin 20 mg + Pioglitazone 30 mg group is to take atorvastatin 20 mg + pioglitazone 30 mg and take follow up PET CT in 3 months | Drug: Atorvastatin 20 mg + Pioglitazone 30 mg<br>* atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months<br>* Other names: Lipitor 20mg plus Actos 30mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of Standardized Uptake Value (SUV) of Atherosclerotic Plaque in Carotid Artery by PET CT |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference PET CT Parameters in 3 Months Compared to Initial Evaluation | Change of Maximum Standardized Uptake Value (SUVmax),Mean Standardized Uptake Value (SUVmean)- no unit for this value | 3 months | 
| Difference of Laboratory Data Compared to Initial Evaluation | Change of high sensitivity C-reactive protein (hsCRP, mg/dl) Change of low density lipoprotein cholesterol(mg/dl) Change of high density lipoprotein cholesterol(mg/dl) Change of triglyceride (mg/dl) Change of matrix metalloproteinase 9 (mcg/ml) Change of plasminogen activator inhibitor (PAI)-1 (ng/ml) Change of Homeostatic Model Assessment (HOMA) index (%) | 3 months | 
| Clinical Incidents | Major adverse cerebro-cardiovascular event: a composite of cardiac death, nonfatal myocardial infarction, stroke, and target vessel revascularization | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Pioglitazone, Atorvastatin, PET CT