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

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Atorvastatin; Pitavastatin

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 twice 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