DyslipidemiasNCT05705804
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
A study testing Pitavastatin, Pitavastatin plus Ezetemibe and Atorvastatin in people with Dyslipidemias and Atherosclerotic Cardiovascular Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dyslipidemias, Atherosclerotic Cardiovascular Disease
- What is being tested?
- Pitavastatin, Pitavastatin plus Ezetemibe and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jun 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Byeong-Keuk Kim, 82-2-2228-8465, KIMBK@yuhs.ac
About this study
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.
- Being tested
- Pitavastatin, Pitavastatin plus Ezetemibe, Atorvastatin
- Medical subject headings
- Dyslipidemias, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Pitavastatin 4 mg will be given.
Pitavastatin plus EzetemibeDrug
Pitvastatin 4 mg plus ezetemibe 10 mg will be given.
AtorvastatinDrug
Atorvastatin 40 mg will be given.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Experimental | Pitavastatin 4mg group Receives: Drug: Pitavastatin |
| Group PE | Experimental | Pitavastatin 4 mg Ezetimibe 10 mg combined administration group Receives: Drug: Pitavastatin plus Ezetemibe |
| Group A | Active comparator | Atorvastatin 40 mg administration group Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 24 weeks
Secondary outcomes (10)
Proportion of fasting glucose ≥100 mg/dL
Measured: At 24 weeks
Proportion of HbA1C ≥6.5%
Measured: At 24 weeks
Proportion of new-onset diabetes mellitus
Measured: At 24 weeks
Changes of HOMA-β at 24 weeks
Measured: At 24 weeks
Changes of fasting glucose at 24 weeks
Measured: At 24 weeks
Changes of insulin at 24 weeks
Measured: At 24 weeks
Changes of HbA1c at 24 weeks
Measured: At 24 weeks
Changes of triglyceride at 24 weeks
Measured: At 24 weeks
LDL-cholesterol change at 24 weeks
Measured: At 24 weeks
HDL-cholesterol change at 24 weeks
Measured: At 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start13 Jun 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byeong-Keuk Kim, Principal investigator, Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705804
- Sponsor's protocol ID
- 4-2022-1325
- Status last verified
- Jul 2026
- First submitted
- 18 Jan 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05705804
- Acronym / sponsor ID
- 4-2022-1325
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group P | Experimental | Drug: PitavastatinPitavastatin 4mg group |
| Group PE | Experimental | Drug: Pitavastatin plus EzetemibePitavastatin 4 mg Ezetimibe 10 mg combined administration group |
| Group A | Active comparator | Drug: AtorvastatinAtorvastatin 40 mg administration group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PitavastatinPitavastatin 4 mg will be given. | Drug | Group P |
| Pitavastatin plus EzetemibePitvastatin 4 mg plus ezetemibe 10 mg will be given. | Drug | Group PE |
| AtorvastatinAtorvastatin 40 mg will be given. | Drug | Group A |
Primary outcome
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.
10 secondary outcomes
Proportion of fasting glucose ≥100 mg/dL
Time frame: At 24 weeks
Proportion of HbA1C ≥6.5%
Time frame: At 24 weeks
Proportion of new-onset diabetes mellitus
Time frame: At 24 weeks
Changes of HOMA-β at 24 weeks
Time frame: At 24 weeks
Changes of fasting glucose at 24 weeks
Time frame: At 24 weeks
Changes of insulin at 24 weeks
Time frame: At 24 weeks
Changes of HbA1c at 24 weeks
Time frame: At 24 weeks
Changes of triglyceride at 24 weeks
Time frame: At 24 weeks
LDL-cholesterol change at 24 weeks
Time frame: At 24 weeks
HDL-cholesterol change at 24 weeks
Time frame: At 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Byeong-Keuk Kim principal investigator
Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pitavastatin, Pitavastatin plus Ezetemibe and Atorvastatin in people with Dyslipidemias and Atherosclerotic Cardiovascular Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Byeong-Keuk Kim (82-2-2228-8465, KIMBK@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks (time frame: At 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.