None listed
Conditions
Interventions
Drug : Group P, Group PE, and Group A will be randomly assigned to each group in a 2:2:1 ratio. Patients assigned to each treatment group will start statin or ezetimibe combination therapy according
-Livalozet Tab. 4/10mg 1TAB PO QD
For Group A, atorvastatin 40 mg is administered.
-Lipilou Tab. 40mg PO QD
-Newvast Tab. 40mg PO QD
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of HOMA-IR | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Korea, Republic of
Contacts
Public ContactSerin Park
Yonsei University Health System, Severance Hospital
Outcome results
None listed