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
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 250
Dyslipidemia (LDL-C =100 mg/dL or while taking existing statins)
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) and no prior diabetes and metabolic syndrome.
1. Diagnosis of clinical atherosclerotic cardiovascular disease within 1 year
2. Acute liver disease or persistent unexplained serum AST or ALT three times the upper limit of normal
3. Allergy or hypersensitivity to statins or ezetimibe
4. Solid organ transplant recipients
5. History of side effects requiring discontinuation of statin administration
6. Pregnant women, potentially pregnant or lactating women
7. Life expectancy less than 3 years
8. If it is judged that follow-up for more than 1 year is not possible
9. If the patient is unable to understand or read the consent form
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of HOMA-IR
- Secondary Outcome Measures
Name Time Method Proportion of fasting glucose =100 mg/dL;Proportion of HbA1C =6.5%;Proportion of new-onset diabetes mellitus;Changes of HOMA-beta;Changes of fasting glucose;Changes of insulin;Changes of HbA1C;Changes of triglyceride;Changes of LDL-Cholesterol;Changes of HDL-Cholesterol