Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-03-01 @ 10:11 AM
Study NCT ID:
NCT03137212
Status:
UNKNOWN
Last Update Posted:
2017-05-02
First Post:
2017-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D013927', 'term': 'Thrombosis'}], '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'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005343', 'term': 'Fibrinolytic Agents'}], 'ancestors': [{'id': 'D050299', 'term': 'Fibrin Modulating Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D006401', 'term': 'Hematologic Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients with STEMI will be divided into two group randomly. Patients of A group will be treated by thrombolysis and then 3-6 hours will be treated by PCI. Patients of B group will be treated by thrombolysis and then 6-24 hours will be treated by PCI.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-30', 'studyFirstSubmitDate': '2017-04-16', 'studyFirstSubmitQcDate': '2017-04-30', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-PCI（percutaneous coronary intervention） myocardial perfusion (TIMI flow grade)', 'timeFrame': 'intraoperative', 'description': 'The investigators will check myocardial perfusion (TIMI flow grade) after PCI （percutaneous coronary intervention）immediately.'}, {'measure': 'The incidence of no reflow', 'timeFrame': 'intraoperative', 'description': 'The investigators will check the incidence of no reflow after PCI（percutaneous coronary intervention） immediately.'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events （MACE）', 'timeFrame': '1 month, 3 month,6 month,12 month', 'description': 'Death and recurrence of myocardial infarction and target vessels revascularization'}, {'measure': 'Post-PCI heart function', 'timeFrame': '1 month, 3 month,6 month,12 month', 'description': 'The value of ejection fraction will be examined by cardiac ultrasound for heart function.'}, {'measure': 'The incidence of serious bleeding events', 'timeFrame': '1 year', 'description': 'The incidence of serious bleeding events including all cause.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous Coronary Intervention', 'STEMI', 'Thrombosis'], 'conditions': ['Acute ST Segment Elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Patients with acute ST-segment elevation myocardial infarction and thrombolysis indications, will be given the recombinant human prourokinase for thrombolysis treatment, and in accordance with the guidelines, will be treated with coronary angiography examination 3 to 24 hours after thrombolysis. The study will explore the best time for interventional therapy combined with thrombolysis.', 'detailedDescription': 'The noninferiority multicenter, prospective, randomized, controlled study of urokinase of restructuring the original design evaluation (rhPro - UK) at different times after thrombolysis combined with percutaneous coronary intervention（PCI）therapy of acute ST segment elevation myocardial infarction.Patients with acute ST segment elevation myocardial infarction and thrombolysis indications, will be given the recombinant human prourokinase for thrombolysis treatment, and in accordance with the guidelines, will be treated with coronary angiography examination 3 to 24 hours after thrombolysis. The study will explore the best time for interventional therapy combined with thrombolysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 19 to 70 years old, gender not limited\n* 30 minutes or more persistent ischemia chest pain, and symptoms can't ease by treated by nitroglycerin\n* In two or more lead ecg ST-segment（the line between QRS complex finish point and the start point of T wave in electrocardiogram) elevation ≥ 0.1mv, or two or more than two neighboring chest lead ST-elevation ≥0.2mv\n* Persistent ischemia chest pain less than 6 hours, door to balloon time\\>90 minutes and transfer time \\>120 minutes\n* Accept coronary arteriography and intervention treatment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy and lactation, menstrual period women\n* Blood disease, clotting hemorrhagic disease, any part of active bleeding or bleeding tendency physique\n* History of trauma in two months, including biopsy and received surgical operation\n* History of the great vessels punctured in two weeks that could not oppression\n* History of ischemic or hemorrhagic stroke and cerebrovascular accident\n* Cardiac shock,reinfarction again, right ventricular myocardial infarction, history of cardiopulmonary resuscitation (CPR)\n* History of PCI or coronary artery bypass grafting（CABG）\n* Killip classification level III（a standard of heart function classification） or above, or cardiac mechanical complications such as cardiac rupture\n* History of eyeground hemorrhage\n* Currently use of therapeutic doses of anticoagulants, such as warfarin, etc\n* Uncontrolled hypertension, systolic blood pressure before thrombolysis is still 160 mmHg or higher, diastolic blood pressure is still 100 mmHg or higher\n* Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks\n* Severe liver and kidney dysfunction\n* Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm\n* Thrombolysis treatment in one week\n* Allergies of thrombolysis drug or contrast\n* Participated in any clinical trials within three months"}, 'identificationModule': {'nctId': 'NCT03137212', 'acronym': 'SEPCIT', 'briefTitle': 'Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Jilin University'}, 'officialTitle': 'Study of Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis by Recombinant Human Prourokinase at Different Time', 'orgStudyIdInfo': {'id': 'SecondJilinU-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A group', 'description': 'STEMI patients first are given thrombolysis and then transfer to PCI center to be treated by PCI 3-6 hours after thrombolysis if the thrombolysis is successful. if the thrombolysis is not successful, patients will be treated by PCI immediately.', 'interventionNames': ['Combination Product: thrombolysis and PCI of A type']}, {'type': 'EXPERIMENTAL', 'label': 'B group', 'description': 'STEMI patients first are given thrombolysis and then transfer to PCI center to be treated by PCI 6-24 hours after thrombolysis if the thrombolysis is successful. if the thrombolysis is not successful, patients will be treated by PCI immediately.', 'interventionNames': ['Combination Product: thrombolysis and PCI of B type']}], 'interventions': [{'name': 'thrombolysis and PCI of A type', 'type': 'COMBINATION_PRODUCT', 'description': 'STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 3-6 hours after thrombolysis.', 'armGroupLabels': ['A group']}, {'name': 'thrombolysis and PCI of B type', 'type': 'COMBINATION_PRODUCT', 'description': 'STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 6-24 hours after thrombolysis.', 'armGroupLabels': ['B group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130041', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Wang, Doctor', 'role': 'CONTACT', 'email': 'wanghe221@163.com', 'phone': '043188796625'}], 'facility': 'The second hospital of Jilin university', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Bin Liu, Doctor', 'role': 'CONTACT', 'email': 'liubin3333@vip.sina.com', 'phone': '043188796598'}, {'name': 'Yongfeng Shi, Doctor', 'role': 'CONTACT', 'email': '32919079@qq.com', 'phone': '043188796625'}], 'overallOfficials': [{'name': 'Bin Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Hospital of Jilin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'when the investigators complete the study and publish our data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}