Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial

Study Overview
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Brief Summary
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The purpose of this study was to investigate the effect of pitavastatin or pitavastatin and ezetimibe combination therapy on glucose metabolism compared to atorvastatin in patients with atherosclerotic cardiovascular disease with metabolic syndrome.

Official Title
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Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial

Conditions
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Dyslipidemias, Atherosclerotic Cardiovascular Disease

Intervention / Treatment
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* Drug: Pitavastatin
* Drug: Pitavastatin plus Ezetemibe
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with dyslipidemia Patient with diagnosis of clinical atherosclerotic cardiovascular disease (acute coronary syndrome, history of myocardial infarction, stable or unstable angina, history of coronary artery reperfusion, stroke or transient stroke, history of peripheral arterial disease or peripheral arterial reperfusion) Patients with metabolic syndrome but without diabetes Exclusion Criteria: Diagnosis of clinical atherosclerotic cardiovascular disease within 1 year Acute liver disease or persistent unexplained serum AST or ALT three times the upper limit of normal Allergy or hypersensitivity to statins or ezetimibe Solid organ transplant recipients History of side effects requiring discontinuation of statin administration Pregnant women, potentially pregnant or lactating women Life expectancy less than 3 years If it is judged that follow-up for more than 1 year is not possible If the patient is unable to understand or read the consent form
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 |
| --- | --- |
| Experimental: Group P<br>Pitavastatin 4mg group | Drug: Pitavastatin<br>* Pitavastatin 4 mg will be given.<br>|
| Experimental: Group PE<br>Pitavastatin 4 mg Ezetimibe 10 mg combined administration group | Drug: Pitavastatin plus Ezetemibe<br>* Pitvastatin 4 mg plus ezetemibe 10 mg will be given.<br>|
| Active Comparator: Group A<br>Atorvastatin 40 mg administration group | Drug: Atorvastatin<br>* Atorvastatin 40 mg will be given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks | Changes of homeostatic model assessment for insulin resistance (HOMA-IR) form baseline to 24 weeks will be compared among the three groups. | At 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of fasting glucose ≥100 mg/dL |  | At 24 weeks | 
| Proportion of HbA1C ≥6.5% |  | At 24 weeks | 
| Proportion of new-onset diabetes mellitus |  | At 24 weeks | 
| Changes of HOMA-β at 24 weeks |  | At 24 weeks | 
| Changes of fasting glucose at 24 weeks |  | At 24 weeks | 
| Changes of insulin at 24 weeks |  | At 24 weeks | 
| Changes of HbA1c at 24 weeks |  | At 24 weeks | 
| Changes of triglyceride at 24 weeks |  | At 24 weeks | 
| LDL-cholesterol change at 24 weeks |  | At 24 weeks | 
| HDL-cholesterol change at 24 weeks |  | At 24 weeks |