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NCT Number: 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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Byeong-Keuk Kim

CONTACT

[email protected]

82-2-2228-8465

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with dyslipidemia
  • 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)
  • Patients with metabolic syndrome but without diabetes

Exclusion criteria

  • Diagnosis of clinical atherosclerotic cardiovascular disease within 1 year
  • Acute liver disease or persistent unexplained serum AST or ALT three times the upper limit of normal
  • Allergy or hypersensitivity to statins or ezetimibe
  • Solid organ transplant recipients
  • History of side effects requiring discontinuation of statin administration
  • Pregnant women, potentially pregnant or lactating women
  • Life expectancy less than 3 years
  • If it is judged that follow-up for more than 1 year is not possible
  • If the patient is unable to understand or read the consent form

Treatment and study plan

Pitavastatin

Drug

Pitavastatin 4 mg will be given.

Pitavastatin plus Ezetemibe

Drug

Pitvastatin 4 mg plus ezetemibe 10 mg will be given.

atorvastatin

Drug

Atorvastatin 40 mg will be given.

Primary outcomes

  1. Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks

    Time frame: At 24 weeks

    Changes of homeostatic model assessment for insulin resistance (HOMA-IR) form baseline to 24 weeks will be compared among the three groups.

Secondary outcomes

  1. Proportion of fasting glucose ≥100 mg/dL

    Time frame: At 24 weeks

  2. Proportion of HbA1C ≥6.5%

    Time frame: At 24 weeks

  3. Proportion of new-onset diabetes mellitus

    Time frame: At 24 weeks

  4. Changes of HOMA-β at 24 weeks

    Time frame: At 24 weeks

  5. Changes of fasting glucose at 24 weeks

    Time frame: At 24 weeks

  6. Changes of insulin at 24 weeks

    Time frame: At 24 weeks

  7. Changes of HbA1c at 24 weeks

    Time frame: At 24 weeks

  8. Changes of triglyceride at 24 weeks

    Time frame: At 24 weeks

  9. LDL-cholesterol change at 24 weeks

    Time frame: At 24 weeks

  10. HDL-cholesterol change at 24 weeks

    Time frame: At 24 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Byeong-Keuk Kim

CONTACT

[email protected]

82-2-2228-8465

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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