Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dyslipidemias
Atherosclerotic Cardiovascular Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks
timeFrame: At 24 weeks
Secondary outcomes:
measure: Proportion of fasting glucose ≥100 mg/dL
timeFrame: At 24 weeks
measure: Proportion of HbA1C ≥6.5%
timeFrame: At 24 weeks
measure: Proportion of new-onset diabetes mellitus
timeFrame: At 24 weeks
measure: Changes of HOMA-β at 24 weeks
timeFrame: At 24 weeks
measure: Changes of fasting glucose at 24 weeks
timeFrame: At 24 weeks
measure: Changes of insulin at 24 weeks
timeFrame: At 24 weeks
measure: Changes of HbA1c at 24 weeks
timeFrame: At 24 weeks
measure: Changes of triglyceride at 24 weeks
timeFrame: At 24 weeks
measure: LDL-cholesterol change at 24 weeks
timeFrame: At 24 weeks
measure: HDL-cholesterol change at 24 weeks
timeFrame: At 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE
name: Byeong-Keuk Kim
role: PRINCIPAL_INVESTIGATOR
References: