Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-29 @ 12:01 AM
Study NCT ID:
NCT05705804
Status:
UNKNOWN
Last Update Posted:
2023-07-06
First Post:
2023-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108475', 'term': 'pitavastatin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-04', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-01-29', 'lastUpdatePostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks', 'timeFrame': '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.'}], 'secondaryOutcomes': [{'measure': 'Proportion of fasting glucose ≥100 mg/dL', 'timeFrame': 'At 24 weeks'}, {'measure': 'Proportion of HbA1C ≥6.5%', 'timeFrame': 'At 24 weeks'}, {'measure': 'Proportion of new-onset diabetes mellitus', 'timeFrame': 'At 24 weeks'}, {'measure': 'Changes of HOMA-β at 24 weeks', 'timeFrame': 'At 24 weeks'}, {'measure': 'Changes of fasting glucose at 24 weeks', 'timeFrame': 'At 24 weeks'}, {'measure': 'Changes of insulin at 24 weeks', 'timeFrame': 'At 24 weeks'}, {'measure': 'Changes of HbA1c at 24 weeks', 'timeFrame': 'At 24 weeks'}, {'measure': 'Changes of triglyceride at 24 weeks', 'timeFrame': 'At 24 weeks'}, {'measure': 'LDL-cholesterol change at 24 weeks', 'timeFrame': 'At 24 weeks'}, {'measure': 'HDL-cholesterol change at 24 weeks', 'timeFrame': 'At 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemias', 'Atherosclerotic Cardiovascular Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with dyslipidemia\n2. 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)\n3. Patients with metabolic syndrome but without diabetes\n\nExclusion Criteria:\n\n1. Diagnosis of clinical atherosclerotic cardiovascular disease within 1 year\n2. Acute liver disease or persistent unexplained serum AST or ALT three times the upper limit of normal\n3. Allergy or hypersensitivity to statins or ezetimibe\n4. Solid organ transplant recipients\n5. History of side effects requiring discontinuation of statin administration\n6. Pregnant women, potentially pregnant or lactating women\n7. Life expectancy less than 3 years\n8. If it is judged that follow-up for more than 1 year is not possible\n9. If the patient is unable to understand or read the consent form'}, 'identificationModule': {'nctId': 'NCT05705804', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '4-2022-1325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group P', 'description': 'Pitavastatin 4mg group', 'interventionNames': ['Drug: Pitavastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Group PE', 'description': 'Pitavastatin 4 mg Ezetimibe 10 mg combined administration group', 'interventionNames': ['Drug: Pitavastatin plus Ezetemibe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Atorvastatin 40 mg administration group', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'Pitavastatin', 'type': 'DRUG', 'description': 'Pitavastatin 4 mg will be given.', 'armGroupLabels': ['Group P']}, {'name': 'Pitavastatin plus Ezetemibe', 'type': 'DRUG', 'description': 'Pitvastatin 4 mg plus ezetemibe 10 mg will be given.', 'armGroupLabels': ['Group PE']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'Atorvastatin 40 mg will be given.', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byeong-Keuk Kim', 'role': 'CONTACT', 'email': 'KIMBK@yuhs.ac', 'phone': '82-2-2228-8465'}], 'facility': 'Yonsei University Health System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Byeong-Keuk Kim', 'role': 'CONTACT', 'email': 'KIMBK@yuhs.ac', 'phone': '82-2-2228-8465'}], 'overallOfficials': [{'name': 'Byeong-Keuk Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}