About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Pitavastatin
DrugPitavastatin 4 mg will be given.
Pitavastatin plus Ezetemibe
DrugPitvastatin 4 mg plus ezetemibe 10 mg will be given.
Atorvastatin
DrugAtorvastatin 40 mg will be given.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Proportion of fasting glucose ≥100 mg/dL
Proportion of HbA1C ≥6.5%
Proportion of new-onset diabetes mellitus
Changes of HOMA-β at 24 weeks
Sponsors and contacts
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