Back to resultsEffects 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
Primary Purpose
Dyslipidemias, Atherosclerotic Cardiovascular Disease
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pitavastatin
Pitavastatin plus Ezetemibe
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias
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
Sites / Locations
- Yonsei University Health System, Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group P
Group PE
Group A
Arm Description
Pitavastatin 4mg group
Pitavastatin 4 mg Ezetimibe 10 mg combined administration group
Atorvastatin 40 mg administration group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of fasting glucose ≥100 mg/dL
Proportion of HbA1C ≥6.5%
Proportion of new-onset diabetes mellitus
Changes of HOMA-β at 24 weeks
Changes of fasting glucose at 24 weeks
Changes of insulin at 24 weeks
Changes of HbA1c at 24 weeks
Changes of triglyceride at 24 weeks
LDL-cholesterol change at 24 weeks
HDL-cholesterol change at 24 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05705804
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Atherosclerotic Cardiovascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group P
Arm Type
Experimental
Arm Description
Pitavastatin 4mg group
Arm Title
Group PE
Arm Type
Experimental
Arm Description
Pitavastatin 4 mg Ezetimibe 10 mg combined administration group
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Atorvastatin 40 mg administration group
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Description
Pitavastatin 4 mg will be given.
Intervention Type
Drug
Intervention Name(s)
Pitavastatin plus Ezetemibe
Intervention Description
Pitvastatin 4 mg plus ezetemibe 10 mg will be given.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 40 mg will be given.
Primary Outcome Measure Information:
Title
Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks
Description
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 Outcome Measure Information:
Title
Proportion of fasting glucose ≥100 mg/dL
Time Frame
At 24 weeks
Title
Proportion of HbA1C ≥6.5%
Time Frame
At 24 weeks
Title
Proportion of new-onset diabetes mellitus
Time Frame
At 24 weeks
Title
Changes of HOMA-β at 24 weeks
Time Frame
At 24 weeks
Title
Changes of fasting glucose at 24 weeks
Time Frame
At 24 weeks
Title
Changes of insulin at 24 weeks
Time Frame
At 24 weeks
Title
Changes of HbA1c at 24 weeks
Time Frame
At 24 weeks
Title
Changes of triglyceride at 24 weeks
Time Frame
At 24 weeks
Title
LDL-cholesterol change at 24 weeks
Time Frame
At 24 weeks
Title
HDL-cholesterol change at 24 weeks
Time Frame
At 24 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byeong-Keuk Kim
Phone
82-2-2228-8465
Email
KIMBK@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byeong-Keuk Kim
Organizational Affiliation
Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byeong-Keuk Kim
Phone
82-2-2228-8465
Email
KIMBK@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
We'll reach out to this number within 24 hrs