Investigating the effects of pitavastatin and ezetimibe on glucose metabolism in patients with cardiovascular disease and metabolic syndrome
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
Run by Yonsei University · NCT05705804 · Data updated 2026-11-12
This study is testing whether the medications pitavastatin alone or with ezetimibe can improve blood sugar levels in people with heart disease and metabolic syndrome who don't have diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | June 13, 2023 |
| Main results expected | February 29, 2028 |
| Study ends | August 5, 2028 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT05705804 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients with dyslipidemia and a diagnosis of atherosclerotic cardiovascular disease who also have metabolic syndrome but do not have diabetes.
✕Probably not a fit
Patients who have recently been diagnosed with atherosclerotic cardiovascular disease, those with acute liver disease, or individuals with a history of severe side effects from statins may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the impact of pitavastatin alone and in combination with ezetimibe on glucose metabolism in patients suffering from atherosclerotic cardiovascular disease and metabolic syndrome. Participants will be compared against those receiving atorvastatin to determine the effectiveness of these treatments. The study focuses on patients with dyslipidemia who do not have diabetes, ensuring a specific target population for the interventions. The trial will assess various metabolic outcomes over a defined period.
Why it matters
Potential benefit: If successful, this study could provide new insights into managing glucose metabolism in patients with cardiovascular disease and metabolic syndrome, potentially leading to improved treatment strategies.
How similar studies have gone: Other studies have explored the effects of statins on metabolic parameters, but this specific combination therapy approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Yonsei University Health System, Severance Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Byeong-Keuk Kim — Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE
- Study coordinator: Byeong-Keuk Kim
- Email: KIMBK@yuhs.ac
- Phone: 82-2-2228-8465
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.