Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)

Study Overview
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Brief Summary
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The purpose of this study is to compare the effects of pitavastatin and atorvastatin on adiponectin percentage change in patients with hypercholesteremia comorbid stable CAD.

Detailed Description
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The efficiency of lipid lowering therapy was already proven by the clinical trials of statins. According to these results, the target value of LDL-C is recommended under 100mg/dL in the Japan Atherosclerosis Society Guidelines. However, the efficiency of intensive therapy to lower LDL-C more than 100mg/dL has not been proven yet.

Official Title
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Comparison of Pitavastatin With Atorvastatin in Increasing HDL-C and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease.

Conditions
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Hypercholesterolemia, Coronary Artery Disease

Intervention / Treatment
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* Drug: Pitavastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with dyslipidemia as defined by any of the parameters: HDL-C < 50 mg/dL LDL-C ≥ 140 mg/dL LDL-C ≥ 100 mg/dL and cholesterol-lowering treatment is necessary in accordance with the investigator's judgement Patients who passed three months or more after acute myocardial infarction Patients who passed one month or more after unstable angina Patients who passed one month or more after PCI Patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial Exclusion Criteria: Patients with any allergy to pitavastatin or atorvastatin Patients with familial hypercholesterolemia Patients receiving pitavastatin Patients with severe hypertension Patients with renal disorders or undergoing dialysis Patients with hepatobiliary disorders Patients with hepatobiliary disorders Patients with family history of hypothyroidism or muscular dystrophy Patients with history of drug-induced hepatic disorder Drug abuser or dipsomaniac Patients with cardiogenic shock. Patients who hopes for pregnancy during this study Contraindications, Relative Contraindications, Absolute Contraindications for Coadministration and Relative Contraindications for Coadministration for pitavastatin or atorvastatin Patients who are ineligible in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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: 1<br>pitavastatin group | Drug: Pitavastatin<br>* comparison of two drugs in increasing HDL-C and adiponectin<br>|
| Active Comparator: 2<br>atorvastatin group | Drug: Atorvastatin<br>* comparison of two drugs in increasing HDL-C and adiponectin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-cholesterol (HDL-C); Adiponectin; High-Molecular- Weight Adiponectin(HMW Adiponectin) |  | start, 6 months, 12 months, 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TC; LDL-C; HDL-C; HDL2-C; HDL3-C; TG; smalldenseLDL; MDA-LDL; FPG; HbA1c; Cr; RLP-C; apoA-I; apoB; apoC-Ⅱ; apoC-Ⅲ |  | start, 6 months, 12 months, 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pitavastatin, Atorvastatin, CAD, HDL-C, Adiponectin