Recruiting NCT05705804
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pitavastatin, Pitavastatin plus Ezetemibe, Atorvastatin.
- Who it may be relevant to
- Registry conditions: Dyslipidemias, Atherosclerotic Cardiovascular Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug Pitavastatin
Pitavastatin 4 mg will be given. - Drug Pitavastatin plus Ezetemibe
Pitvastatin 4 mg plus ezetemibe 10 mg will be given. - Drug Atorvastatin
Atorvastatin 40 mg will be given.
Primary outcome measures
- Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks [Time frame: At 24 weeks]
Secondary outcome measures (10)
- Proportion of fasting glucose ≥100 mg/dL [Time frame: At 24 weeks]
- Proportion of HbA1C ≥6.5% [Time frame: At 24 weeks]
- Proportion of new-onset diabetes mellitus [Time frame: At 24 weeks]
- Changes of HOMA-β at 24 weeks [Time frame: At 24 weeks]
- Changes of fasting glucose at 24 weeks [Time frame: At 24 weeks]
- Changes of insulin at 24 weeks [Time frame: At 24 weeks]
- Changes of HbA1c at 24 weeks [Time frame: At 24 weeks]
- Changes of triglyceride at 24 weeks [Time frame: At 24 weeks]
- LDL-cholesterol change at 24 weeks [Time frame: At 24 weeks]
- HDL-cholesterol change at 24 weeks [Time frame: At 24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Yonsei University Health System, Severance Hospital — Seoul
Identifiers
NCT: NCT05705804 · 4-2022-1325