Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT02588235
Status:
UNKNOWN
Last Update Posted:
2015-10-27
First Post:
2015-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ezetimibe and Atorvastatin Therapy on TCFA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-26', 'studyFirstSubmitDate': '2015-10-26', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'minimum fibrous cap thickness', 'timeFrame': '12months', 'description': 'The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method. Angiographic and OCT follow-up will be scheduled for the target vessel after 12 months.', 'detailedDescription': 'This is a prospective, randomized , controlled, open-label, single-center study to evaluate the effect of ezetimibe added to atorvastatin on coronary thin-cap fibroatheroma(TCFA). After successful coronary angiography and OCT examination, patients with TCFAs in non-culprit, mild-to-moderate stenotic lesions will be enrolled. Then, they will be randomly assigned in a 1:1 ratio to receive either atorvastatin (20 mg/day) alone or atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）by envelope method.\n\nAngiographic and OCT follow-up will be scheduled for the target vessel after 12 months.The primary efficacy endpoint is the change in minimum fibrous cap thickness measured by OCT from baseline to follow-up.The secondary endpoints include absolute and percent changes in the lipid, glycemic, and inflammatory profile. Then, changes of these indicators above will be compared respectively in diabetic and non-diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1.stable angina or acute coronary syndrome 2.18-80 years old 3.hypercholesterolemia :total cholesterol level \\>220 mg/dl (5.7mmol/L) and/or LDL-C level \\>140 mg/dl(3.6mmol/L), or previously receiving statins therapy 4. the target vessel for OCT interrogation has not undergone angioplasty and has angiographic diameter stenosis from 25% to 75% 5.There are TCFAs in non-culprit, mild-to-moderate stenotic lesions above\n\nExclusion Criteria:\n\n1. administration of lipid-lowering drugs other than statins before enrollment\n2. significant stenotic lesions in all coronary vessels\n3. severe congestive heart failure (New York Heart Association class IV) ,or left ventricular ejection fraction\\<35%\n4. more than 3 times of the upper limit of normal (ULN) in the creatine kinase (CK) and the transaminase level before enrollment and no relation with myocardial infarction\n5. renal failure (serum creatinine\\>2.0 mg/dL）\n6. hypersensitivity to x-ray contrast media, statin，clopidogrel or ezetimibe\n7. Others: terminal stage cancer,a positive pregnancy test'}, 'identificationModule': {'nctId': 'NCT02588235', 'briefTitle': 'Ezetimibe and Atorvastatin Therapy on TCFA', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Impact of Combined Ezetimibe and Atorvastatin Therapy on Coronary Thin-cap Fibroatheroma As Assessed by Optical Coherence Tomography', 'orgStudyIdInfo': {'id': 'TCFA-OCT XIJING01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ezetimibe and Atorvastatin Therapy', 'description': 'Atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）', 'interventionNames': ['Drug: Ezetimibe and Atorvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin Therapy', 'description': 'Atorvastatin (20 mg/day）', 'interventionNames': ['Drug: Atorvastatin']}], 'interventions': [{'name': 'Ezetimibe and Atorvastatin', 'type': 'DRUG', 'otherNames': ['Ezetrol and lipitor'], 'description': 'atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）', 'armGroupLabels': ['Ezetimibe and Atorvastatin Therapy']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': 'atorvastatin (20 mg/day）', 'armGroupLabels': ['Atorvastatin Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongdong Sun, M.D., Ph.D.', 'role': 'CONTACT'}], 'facility': 'Xijing Hospital, Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Dongdong Sun, M.D., Ph.D.', 'role': 'CONTACT', 'email': '51483696@qq.com', 'phone': '86 29 84775183'}], 'overallOfficials': [{'name': 'Yan Li, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending', 'investigatorFullName': 'sunddong', 'investigatorAffiliation': 'Xijing Hospital'}}}}