Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-16 @ 1:31 AM
Study NCT ID:
NCT02131220
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2014-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intracoronary Prourokinase on the Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D054318', 'term': 'No-Reflow Phenomenon'}], 'ancestors': [{'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': 'C067551', 'term': 'saruplase'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D000077466', 'term': 'Tirofiban'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014443', 'term': 'Tyrosine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-04', 'studyFirstSubmitDate': '2014-05-03', 'studyFirstSubmitQcDate': '2014-05-03', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'TIMI defined total major bleeding', 'timeFrame': '30 days post PCI'}], 'primaryOutcomes': [{'measure': 'Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)', 'timeFrame': 'At the end of Percutaneous Coronary Intervention procedure'}], 'secondaryOutcomes': [{'measure': 'ST segment resolution in ECG', 'timeFrame': '3 hours post PCI procedure'}, {'measure': 'peak troponin T level', 'timeFrame': 'in the 7 days post PCI procedure'}, {'measure': 'plasma N terminal-proBNP levels', 'timeFrame': '1 and 30 days post PCI procedure'}, {'measure': 'infarction area confirmed by SPECT', 'timeFrame': '30 days post PCI'}, {'measure': 'incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization', 'timeFrame': '30 days post PCI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['No-Reflow Phenomenon'], 'conditions': ['Myocardial Infarction', 'Percutaneous Coronary Intervention', 'Thrombolytic Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ST-segment elevation AMI within 12 hours of symptom onset\n\nExclusion Criteria:\n\n* Contraindications to thrombolysis or PCI\n* Patients administered a fibrinolytic agent before PCI\n* Patients enrolled in clinical trials'}, 'identificationModule': {'nctId': 'NCT02131220', 'acronym': 'ERUPTION', 'briefTitle': 'Effects of Intracoronary Prourokinase on the Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Randomized, Parallel-controlled, Multi-center Study of the Effects of Intracoronary Recombinant HUman Prourokinase or TIrofiban on the Coronary Flow During Primary PCI for the Acute Myocardial InfartiON', 'orgStudyIdInfo': {'id': 'Zhongshan 2012-134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prourokinase', 'description': 'Intracoronary bolus infusion of 20mg prourokinase using selective catheter', 'interventionNames': ['Drug: Prourokinase']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tirofiban', 'description': 'Intracoronary tirofiban bolus infusion using selective catheter (10ug/kg)', 'interventionNames': ['Drug: Tirofiban']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Intracoronary saline bolus infusion using selective catheter (20ml)', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Prourokinase', 'type': 'DRUG', 'otherNames': ['Reocmbinant Human Prourokinase for Injection', 'TIANJIN TASLY PHARMACEUTICAL CO.,LTD'], 'description': '20mg intracoronary bolus infusion using selective catheter during PCI', 'armGroupLabels': ['Prourokinase']}, {'name': 'Tirofiban', 'type': 'DRUG', 'otherNames': ['Grand Pharmr (China) Co. Ltd'], 'description': '10ug/kg intracoronary bolus infusion using selective catheter during PCI', 'armGroupLabels': ['Tirofiban']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'intracoronary bolus infusion using selective catheter during PCI', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Cardiology, Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Junbo Ge, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Dept. of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital', 'investigatorFullName': 'Ge Junbo', 'investigatorAffiliation': 'Fudan University'}}}}