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

Dyslipidemias Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705804
• Other study ID #: 4-2022-1325
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: April 2025

Study information

• Verified date: July 2023
• Source: Yonsei University
• Contact: Byeong-Keuk Kim
• Phone: 82-2-2228-8465
• Email: KIMBK[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Dyslipidemias
• Metabolic Syndrome

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 24 weeks
Secondary	Proportion of fasting glucose =100 mg/dL		At 24 weeks
Secondary	Proportion of HbA1C =6.5%		At 24 weeks
Secondary	Proportion of new-onset diabetes mellitus		At 24 weeks
Secondary	Changes of HOMA-ß at 24 weeks		At 24 weeks
Secondary	Changes of fasting glucose at 24 weeks		At 24 weeks
Secondary	Changes of insulin at 24 weeks		At 24 weeks
Secondary	Changes of HbA1c at 24 weeks		At 24 weeks
Secondary	Changes of triglyceride at 24 weeks		At 24 weeks
Secondary	LDL-cholesterol change at 24 weeks		At 24 weeks
Secondary	HDL-cholesterol change at 24 weeks		At 24 weeks