Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 1:15 AM
Study NCT ID:
NCT01033058
Status:
UNKNOWN
Last Update Posted:
2009-12-24
First Post:
2009-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-23', 'studyFirstSubmitDate': '2009-12-15', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The combined endpoint of 90-day all cause morality, cardiac death, recurrent MI, recurrent symptomatic myocardiac ischemia, target vessel revascularization', 'timeFrame': '2009 Dec- 2011 Mar'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['STEMI', 'atorvastatin', 'PCI'], 'conditions': ['STEMI']}, 'descriptionModule': {'briefSummary': 'This is a retrospective, randomized, parallel, open-labeled, controlled study to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.', 'detailedDescription': 'ARMYDA-ACS, ARMYDA-RECAPTURE and NAPLES II demonstrated that in patients with ASP and NSTE ACS undergoing early PCI, loading dose of atorvastatin before early PCI led to a reduction of prei-PCI MI, recurrent CV events and mortality. While, theses studies included patients with non-ST-segment elevation ACS, requiring PCI; these results cannot be extrapolated directly to patients with ST-segment elevation MI, and these trials included patients sent to an early and selective PCI, but not those undergoing emergency revascularization;\n\nThis study is designed to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-75 years old\n* myocardiac ischemia symptom of index event appeared less than 12 hours before enrollment.\n* ECG showed elevated ST segment in 3 or more contiguous leads\n* diagnosed with acute STEMI\n* eligible for primary PCI, and primary PCI is scheduled within 2 hours after enrollment\n\nExclusion Criteria:\n\n* allergic or experienced serious adverse reaction to HMG-CoA reductase\n* pregnancy, lactation, or child bearing potential women without any effective contraception\n* accompanied with malignant disease\n* active hepatic disease or hepatic dysfunction'}, 'identificationModule': {'nctId': 'NCT01033058', 'briefTitle': 'Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Effect of Intensive Statin Treatment on 90-day Prognosis of STEMI Patients Undergoing Emergency Primary PCI Compared With Usual Care', 'orgStudyIdInfo': {'id': 'CHN2009CV005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'usual care', 'interventionNames': ['Drug: atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'intensive statin treatment', 'interventionNames': ['Drug: atorvastatin']}], 'interventions': [{'name': 'atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': '80mg atorvastatin immediately after enrollment, emergency PCI,atorvastatin 40mg/d and other usual medication after PCI', 'armGroupLabels': ['intensive statin treatment']}, {'name': 'atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor'], 'description': 'No loading dose of statin after enrollment, emergency PCI, atorvastatin 20mg/d and other usual medication after PCI', 'armGroupLabels': ['usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Chaoyang', 'country': 'China', 'contacts': [{'name': 'Yanying Shen, Dr.', 'role': 'CONTACT', 'phone': '85201000'}, {'name': 'Xinchun Yang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chaoyang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xinchun Yang, Prof.', 'role': 'CONTACT', 'email': 'yangxc@medmail.com.cn', 'phone': '+86 10 85231937'}], 'overallOfficials': [{'name': 'Xinchun Yang, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chaoyang Hospital, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Prof. Yang Xinchun', 'oldOrganization': 'Beijing Chaoyang Hospital'}}}}