Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT04056169
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2019-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2019-08-08', 'studyFirstSubmitQcDate': '2019-08-08', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change in most-diseased segment (MDS)-tissue blood ratio (TBR) of the index vessel', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Change in MDS TBR', 'timeFrame': '6 months'}, {'measure': 'Change in whole vessel TBR within the index vessel', 'timeFrame': '6 months'}, {'measure': 'Change in whole vessel TBR of the aorta', 'timeFrame': '6 months'}, {'measure': 'Change in total cholesterol', 'timeFrame': '6 months'}, {'measure': 'Change in triglyceride', 'timeFrame': '6 months'}, {'measure': 'Change in HDL-cholesterol', 'timeFrame': '6 months'}, {'measure': 'Change in LDL-cholesterol', 'timeFrame': '6 months'}, {'measure': 'Change in high sensitive C-reactive protein', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rosuvastatin', 'ezetimibe/rosuvastatin', 'carotid plaque inflammation', 'fluorodeoxyglucose F18', 'positron emission tomography'], 'conditions': ['Acute Coronary Syndrome', 'Carotid Atherosclerotic Plaque With Inflammation']}, 'descriptionModule': {'briefSummary': 'Combination therapy of ezetimibe with a low-dose statin is occasionally used to avoid statin-related side effects in clinical practice among patients with atherosclerotic cardiovascular disease. This approach is equivalent to high-dose statin therapy to decrease LDL cholesterol level by \\>50%, allowing such patients to achieve LDL cholesterol target. However, it remains uncertain whether combination therapy with ezetimibe and low-dose statin verse high-dose statin monotherapy similarily suppress atherosclerotic plaque inflammation. This study is to compare high-dose rosuvastatin versus low-dose rosuvastatin plus ezetimibe on carotid plaque inflammation in patients with acute coronary syndrome using 18F-fluorodeoxyglucose (18FDG) positron emission tomography (PET) imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged ≥ 19 years\n2. acute coronary syndrome, carotid artery disease (diameter stenosis 20-50%), and at least one 18FDG uptake lesion in the carotid artery (target to background ratio (TBR) ≥ 1.6) by 18FDG PET/CT imaging\n3. written consent\n\nExclusion Criteria:\n\n1. previous history of carotid endarterectomy or stenting\n2. schedule for cardiac or major surgery within the next 6 months\n3. statin or ezetimibe therapy in the past 4 weeks\n4. chronic disease needed to be treated with oral, intravenous, or intraarticular steroid\n5. end-stage renal disease\n6. chronic liver disease\n7. history of cancers within the past 3 years\n8. pregnant, breast-feeding or child-bearing potential\n9. expected life expectancy within 2 years'}, 'identificationModule': {'nctId': 'NCT04056169', 'briefTitle': 'Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'Comparison of High-dose Rosuvastatin Versus Low-dose Rosuvastatin Plus Ezetimibe on Carotid Plaque Inflammation in Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'seeCAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rosuvastatin', 'description': 'rosuvastatin 20 mg once a day for 6 months', 'interventionNames': ['Drug: high-dose rosuvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'ezetimibe/rosuvastatin', 'description': 'ezetimibe/rosuvastatin 10/5 mg once a day for 6 months', 'interventionNames': ['Drug: low-dose rosuvastatin plus ezetimibe']}], 'interventions': [{'name': 'high-dose rosuvastatin', 'type': 'DRUG', 'description': 'rosuvastatin 20 mg once a day for 6 months', 'armGroupLabels': ['Rosuvastatin']}, {'name': 'low-dose rosuvastatin plus ezetimibe', 'type': 'DRUG', 'description': 'ezetimibe/rosuvastatin 10/5 mg once a day for 6 months', 'armGroupLabels': ['ezetimibe/rosuvastatin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}