Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00723320
Status:
UNKNOWN
Last Update Posted:
2008-08-25
First Post:
2008-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Atorvastatin and Lifestyle Intervention on Progression of Pre-Clinical Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-08-22', 'studyFirstSubmitDate': '2008-07-21', 'studyFirstSubmitQcDate': '2008-07-24', 'lastUpdatePostDateStruct': {'date': '2008-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The progress of CIMT', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'The progress of ABI', 'timeFrame': '2 years'}, {'measure': 'The progress of PWV', 'timeFrame': '2 years'}, {'measure': 'Occurrence of atherosclerotic disease', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atherosclerosis', 'Atorvastatin', 'Therapeutic lifestyle change', 'CIMT', 'ABI', 'PWV'], 'conditions': ['Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether atorvastatin, aggressive lifestyle intervention, and their interaction are effective in delaying the progress of pre-clinical atherosclerosis.', 'detailedDescription': "Primary prevention of atherosclerotic disease remains a big challenge. Currently, it is not clear how to treat those subjects with evidence of pre-clinical atherosclerosis but without obvious conventional risk factors. This randomized, placebo controlled, double blind study is to evaluate the effect of Atorvastatin 10 mg daily, therapeutic lifestyle change, and their combination, on the progression of CIMT in those with higher baseline CIMT value but are not belong to 'high risk' category, according to the conventional risk factors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CIMT is not less than 0.9 mm\n* without Clinical diagnosis of atherosclerotic disease\n* without Diabetes'}, 'identificationModule': {'nctId': 'NCT00723320', 'acronym': 'EALIPPCA', 'briefTitle': 'Effect of Atorvastatin and Lifestyle Intervention on Progression of Pre-Clinical Atherosclerosis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Science and Technology of the People´s Republic of China'}, 'officialTitle': 'Effect of Atorvastatin and Lifestyle Intervention on Progression of Carotid Intima-Media Thickness in Chinese People Without Manifest Atherosclerotic Disease', 'orgStudyIdInfo': {'id': '2006BAI01A02-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'P+N', 'description': 'placebo without lifestyle intervention'}, {'type': 'EXPERIMENTAL', 'label': 'D+N', 'description': 'Atorvastatin 10mg/d', 'interventionNames': ['Drug: Atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'P+A', 'description': 'lifestyle intervention without Atorvastatin', 'interventionNames': ['Behavioral: Aggressive lifestyle intervention']}, {'type': 'EXPERIMENTAL', 'label': 'D+A', 'description': 'lifestyle intervention and Atorvastatin 10mg/d', 'interventionNames': ['Drug: Atorvastatin', 'Behavioral: Aggressive lifestyle intervention']}], 'interventions': [{'name': 'Atorvastatin', 'type': 'DRUG', 'description': 'atorvastatin 10mg/d', 'armGroupLabels': ['D+A', 'D+N']}, {'name': 'Aggressive lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'aggressive lifestyle intervention', 'armGroupLabels': ['D+A', 'P+A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'role': 'CONTACT', 'email': 'lijianping@medmail.com.cn'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jianping Li', 'role': 'CONTACT', 'phone': '86-10-66551122', 'phoneExt': '5262'}], 'overallOfficials': [{'name': 'Jianping Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Science and Technology of the People´s Republic of China', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Peking University First Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Yong Huo', 'oldOrganization': 'Peking University First Hospital'}}}}