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
NCT ID: NCT05705804
Last Updated: 2023-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2023-06-13
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group P
Pitavastatin 4mg group
Pitavastatin
Pitavastatin 4 mg will be given.
Group PE
Pitavastatin 4 mg Ezetimibe 10 mg combined administration group
Pitavastatin plus Ezetemibe
Pitvastatin 4 mg plus ezetemibe 10 mg will be given.
Group A
Atorvastatin 40 mg administration group
Atorvastatin
Atorvastatin 40 mg will be given.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Byeong-Keuk Kim
Role: PRINCIPAL_INVESTIGATOR
Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE
Locations
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Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2022-1325
Identifier Type: -
Identifier Source: org_study_id
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