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

NCT05705804 — Not applicable, Recruiting, 250 participants, Yonsei University

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Registry	NCT05705804
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	250 (Estimated)
Sponsor	Yonsei University (Other)
Conditions	Dyslipidemias, Atherosclerotic Cardiovascular Disease
Interventions	Pitavastatin, Pitavastatin plus Ezetemibe, Atorvastatin (Drug)
Dates	start 2023-06-13, primary completion 2027-05-01 (estimated), completion 2027-06-01 (estimated), first posted 2023-01-31, last updated 2026-07-07
Locations	1 site in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group P	Experimental	Drug: Pitavastatin	Pitavastatin 4mg group
Group PE	Experimental	Drug: Pitavastatin plus Ezetemibe	Pitavastatin 4 mg Ezetimibe 10 mg combined administration group
Group A	Active comparator	Drug: Atorvastatin	Atorvastatin 40 mg administration group

Pitavastatin (Drug): Pitavastatin 4 mg will be given.
Pitavastatin plus Ezetemibe (Drug): Pitvastatin 4 mg plus ezetemibe 10 mg will be given.
Atorvastatin (Drug): Atorvastatin 40 mg will be given.

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
Yonsei University Health System, Severance Hospital	Seoul	South Korea	Recruiting

+Investigators

Byeong-Keuk Kim, Principal investigator, Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE