Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-29 @ 1:14 PM
Study NCT ID:
NCT01245803
Status:
UNKNOWN
Last Update Posted:
2010-11-23
First Post:
2010-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-22', 'studyFirstSubmitDate': '2010-11-22', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peri-procedural myocardial damage', 'timeFrame': '48 hours after PCI'}], 'secondaryOutcomes': [{'measure': 'MACE', 'timeFrame': '30 days after PCI'}]}, 'conditionsModule': {'keywords': ['rosuvastatin', 'angioplasty', 'acute coronary syndrome'], 'conditions': ['Acute Coronary Syndrome', 'Angioplasty']}, 'descriptionModule': {'briefSummary': 'Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 year old\n* diagnosed as acute coronary syndrome\n* Plan to PCI\n\nExclusion Criteria:\n\n* STEMI patient\n* emergency PCI(\\<2h) for NSTE-ACS\n* History of liver disease and myopathy (ALT/AST\\>3 x upper limit of normal,CK\\>5 x upper limit of normal)\n* TG\\>500mg/dl,CCr\\<30ml/min\n* inflammatory disease\n* allergic to rosuvastatin\n* nephrotic syndrome,hypothyroidism,systemic lupus erythematosus,myeloma,et.al.'}, 'identificationModule': {'nctId': 'NCT01245803', 'acronym': 'AVATAR', 'briefTitle': 'Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': '6998'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rosuvastatin,one month,lipid lowering', 'description': 'additional rosuvastatin(10mg) is given at 18hr and 4-6hr before PCI', 'interventionNames': ['Drug: additional rosuvastatin loading']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sugar pill, one month', 'description': 'sugar pill is given 18-24hr and 4-6hr before PCI as control', 'interventionNames': ['Drug: placebo control']}], 'interventions': [{'name': 'additional rosuvastatin loading', 'type': 'DRUG', 'description': 'additional rosuvastatin (10mg p.o.)is given at 18 hours and 4-6 hours before PCI', 'armGroupLabels': ['rosuvastatin,one month,lipid lowering']}, {'name': 'placebo control', 'type': 'DRUG', 'description': 'sugar pill is given 18-24hr and 4-6hr before PCI as control', 'armGroupLabels': ['sugar pill, one month']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'the 28th division, Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shujjuan Cheng, MD, PhD', 'role': 'CONTACT', 'email': 'chengshujuan1@yahoo.com.cn', 'phone': '+861064456995'}, {'name': 'Shiying Li, MD', 'role': 'CONTACT', 'email': 'yingying2000@gmail.com', 'phone': '+861064456541'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'HYan', 'oldOrganization': 'BeijingAnzhen'}}}}