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
| NCT ID | NCT05705804 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Dyslipidemias |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-06-13 |
| Primary Completion | 2028-02-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2023-06-13 with a primary completion date of 2028-02-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Byeong-Keuk Kim
PRINCIPAL INVESTIGATOR
Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE
Frequently Asked Questions
Who can join the NCT05705804 clinical trial?
This trial is open to participants of all sexes, studying Dyslipidemias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05705804 currently recruiting?
Yes, NCT05705804 is actively recruiting participants. Contact the research team at KIMBK@yuhs.ac for enrollment information.
Where is the NCT05705804 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05705804 clinical trial?
NCT05705804 is sponsored by Yonsei University. The principal investigator is Byeong-Keuk Kim at Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE. The trial plans to enroll 250 participants.