Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01086020
Status:
UNKNOWN
Last Update Posted:
2011-04-04
First Post:
2010-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Atorvastatin Plus Ezetimibe on Coronary Plaque Progression
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': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], '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'}, {'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': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-01', 'studyFirstSubmitDate': '2010-03-11', 'studyFirstSubmitQcDate': '2010-03-11', 'lastUpdatePostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of coronary artery plaque volume', 'timeFrame': '1 year', 'description': 'The primary endpoint was the change of coronary artery plaque volume measured by intravascular ultrasound (IVUS) at one year after randomization.'}], 'secondaryOutcomes': [{'measure': 'composite of adverse cardiac events', 'timeFrame': '2 years', 'description': 'The secondary endpoint was the composite of adverse cardiac events (MACE), including cardiac death, non-fatal infarction and target vessel revascularization at two years after randomization.'}]}, 'conditionsModule': {'keywords': ['IVUS', 'coronary plaque', 'regression'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Atherosclerosis is a progressive disease. Lipid lowering therapy was the standard treatment for patients with coronary artery disease. Studies indicated that coronary artery plaque progression had positive relationship with the plasma cholesterol level, and could be halted or reversed by intensive statin therapy (such as 20-40 mg/d atorvastatin). Ezetimibe plus statin could further lowered blood cholesterol level. Here the investigators hypothesize that same cholesterol lowering level by routing dose of atorvastatin or lower dose of atorvastatin plus ezetimibe could achieve the same effect on coronary artery plaque cessation or regression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to receive the coronary angiography and potential PCI therapy\n\nExclusion Criteria:\n\n* Patients was treated by statins before randomization\n* Patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion\n* ST elevation myocardial infarction less than 7 days\n* Without informed consent\n* Abnormal liver function before randomization, (AST, ALT ≥ULN)\n* Active hepatitis or muscular disease\n* Impaired renal function with serum creatinine level \\> 3mg/dl\n* Impaired left ventricular function with LVEF \\> 30%\n* Participate in other studies'}, 'identificationModule': {'nctId': 'NCT01086020', 'acronym': 'AEPP', 'briefTitle': 'Atorvastatin Plus Ezetimibe on Coronary Plaque Progression', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Same Lipid Lowering by Atorvastatin Versus Atorvastatin Plus Ezetimibe on Coronary Plaque Progression', 'orgStudyIdInfo': {'id': 'RJH20100101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'atorvastatin', 'description': 'patients will be treated with atorvastatin 10mg/d after randomization, and continued for two years', 'interventionNames': ['Drug: atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'atorvastatin and ezetimibe', 'description': 'patients will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d after randomization, and continued for two years', 'interventionNames': ['Drug: atorvastatin plus ezetimibe']}], 'interventions': [{'name': 'atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': 'Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years', 'armGroupLabels': ['atorvastatin']}, {'name': 'atorvastatin plus ezetimibe', 'type': 'DRUG', 'otherNames': ['Lipitor and ezetrol'], 'description': 'Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d for two years', 'armGroupLabels': ['atorvastatin and ezetimibe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruiyan Zhang, MD', 'role': 'CONTACT', 'email': 'zhangruiyan@263.net', 'phone': '862164370045', 'phoneExt': '665215'}, {'name': 'Xin Chen, MD', 'role': 'CONTACT', 'email': 'rjchenxin@yahoo.com.cn', 'phone': '862164370045', 'phoneExt': '665380'}, {'name': 'Ruiyan Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruijin Hospital,', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ruiyan Zhang, MD', 'role': 'CONTACT', 'email': 'zhangruiyan@263.net', 'phone': '862164370045', 'phoneExt': '665215'}, {'name': 'xin Chen, MD', 'role': 'CONTACT', 'phone': '862164370045'}], 'overallOfficials': [{'name': 'Weifeng Shen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Weifeng Shen', 'oldOrganization': 'ruijin hospital, shanghai jiao tong university school of medicine'}}}}