Effects of Pitavastatin or Combination of Pitavastatin an... | NCT05705804

Studies
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

NCT05705804

Sponsor

Yonsei University

Status

Recruiting

Last Update Posted

Jul 7, 2026Actual

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Dyslipidemias
Atherosclerotic Cardiovascular Disease

Interventions

Pitavastatin
Pitavastatin plus Ezetemibe
Atorvastatin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2023Actual

Primary Completion Date

May 1, 2027Estimated

Completion Date

Jun 1, 2027Estimated

First Submitted Date

Jan 18, 2023

First Submission Date that Met QC Criteria

Jan 29, 2023

First Posted Date

Jan 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2026

Last Update Posted Date

Jul 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group P	Experimental	Pitavastatin 4mg group	Drug: Pitavastatin
Group PE	Experimental	Pitavastatin 4 mg Ezetimibe 10 mg combined administration group	Drug: Pitavastatin plus Ezetemibe
Group A	Active Comparator	Atorvastatin 40 mg administration group	Drug: Atorvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pitavastatin	Drug	Pitavastatin 4 mg will be given.	Group P
Pitavastatin plus Ezetemibe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	At 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of fasting glucose ≥100 mg/dL		At 24 weeks
Proportion of HbA1C ≥6.5%		At 24 weeks
Proportion of new-onset diabetes mellitus

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Byeong-Keuk Kim	Contact	82-2-2228-8465		KIMBK@yuhs.ac

Overall Officials

Name	Affiliation	Role
Byeong-Keuk Kim	Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University Health System, Severance Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D050171	Dyslipidemias
D050197	Atherosclerosis

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006538	Heptanoic Acids
D005227	Fatty Acids
D008055	Lipids