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

Yonsei University

Status: Enrolling

Conditions: Atherosclerotic Cardiovascular Disease; Dyslipidemias

Treatments: Drug: Pitavastatin; Drug: Pitavastatin plus Ezetemibe; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05705804

4-2022-1325

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 3 patient groups

Group P

Experimental group

Description:

Pitavastatin 4mg group

Treatment:

Drug: Pitavastatin

Group PE

Experimental group

Description:

Pitavastatin 4 mg Ezetimibe 10 mg combined administration group

Treatment:

Drug: Pitavastatin plus Ezetemibe

Group A

Active Comparator group

Description:

Atorvastatin 40 mg administration group

Treatment:

Drug: Atorvastatin