Atherosclerotic Cardiovascular Disease, Dyslipidemias
Conditions
Brief summary
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.
Interventions
DRUGPitavastatin
Pitavastatin 4 mg will be given.
Pitvastatin 4 mg plus ezetemibe 10 mg will be given.
DRUGAtorvastatin
Atorvastatin 40 mg will be given.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients with dyslipidemia 2. 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) 3. Patients with metabolic syndrome but without diabetes
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 | Description |
|---|---|---|
| Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks | 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. |
Secondary
| Measure | 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 |
Countries
South Korea
Contacts
CONTACTByeong-Keuk Kim
PRINCIPAL_INVESTIGATORByeong-Keuk Kim
Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE
Outcome results
None listed