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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorYonsei University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 3 treatment groups
Group A: Group PExperimental treatment 1 intervention
Group B: Group PEExperimental treatment 1 intervention
Group C: Group AActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) 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.

Time frame
At 24 weeks

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

Other outcomes

Sponsors and contacts

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