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

Not Applicable

Recruiting

• Conditions: Dyslipidemias; Atherosclerotic Cardiovascular Disease
• Interventions: Drug: Pitavastatin plus Ezetemibe; Drug: Atorvastatin; Drug: Pitavastatin

• Registration Number: NCT05705804
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-29
• Study First Posted: 2023-01-31
• Study Start: 2023-06-13
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group PE	Pitavastatin plus Ezetemibe	Pitavastatin 4 mg Ezetimibe 10 mg combined administration group
Group A	Atorvastatin	Atorvastatin 40 mg administration group
Group P	Pitavastatin	Pitavastatin 4mg group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
HDL-cholesterol change at 24 weeks	At 24 weeks
Changes of insulin at 24 weeks	At 24 weeks
Changes of fasting glucose at 24 weeks	At 24 weeks
Changes of HbA1c at 24 weeks	At 24 weeks
LDL-cholesterol change at 24 weeks	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
Proportion of fasting glucose ≥100 mg/dL	At 24 weeks
Changes of triglyceride at 24 weeks	At 24 weeks

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of