Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT06194968
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014568', 'term': 'Urokinase-Type Plasminogen Activator'}, {'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-22', 'studyFirstSubmitDate': '2023-11-10', 'studyFirstSubmitQcDate': '2023-12-22', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Rankin scale (mRS) 0-2 (good functional outcome) at day 90', 'timeFrame': 'at day 90'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to to compare the safety and effectiveness of IV urokinase with IV alteplase in the treatment of AIS in patients up to 6 hours from symptom onset.', 'detailedDescription': 'Recombinant tissue plasminogen activator (alteplase) is currently the recommended treatment of AIS in patients within 0 to 4.5 hours from symptom onset. The cost of a single treatment with this drug is around 5000 RMB (about 700 USD). In contrast, the cost of a single dose of urokinase is around 300 RMB (about 40 USD), making it much more affordable. Currently, existing evidence regarding the effectiveness and safety of urokinase is mixed. Some studies propose that urokinase thrombolysis, compared with alteplase thrombolysis, improves perfusion without increasing the incidence of adverse reactions and mortality. In some cases, using urokinase for thrombolysis even lowers the risk of systemic bleeding, comparing to alteplase. Other studies suggest that the effectiveness and safety of urokinase intreating AIS patients is infeiror comparing to alteplase . In this study, we plan to conduct a nationwide multicenter real-world study on urokinase intravenous thrombolysis with alteplase as an active control. We will observe and analyze AIS patients treated with urokinase and alteplase and compare the effectiveness, safety and economic effects. We will explore different urokinase dosage efficacy indicators and analyze relevant risk factors. This will provide data for future systematic evaluations of the clinical effects of urokinase thrombolysis which may help lower the medical costs in treating AIS while ensuring the effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute ischemic stroke who meet all inclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:Age: ≥18 years. Clinical diagnosis of acute ischemic stroke, defined as an event characterized by the sudden onset of an acute focal neurologic deficit, unilateral motor dysfunction or impairment of language presumed to be due to cerebral ischemia after, with imaging evidence of a causative lesion or symptoms/signs persisting for over 24 hours. CT scan should exclude hemorrhage and non-vascular etiology.\n\nFirst-time occurrence or a history of stroke without significant neurological deficits (baseline mRS score ≤ 1).\n\nEligible for treatment with intravenous administration of urokinase or alteplase as assessed by the investigators.\n\nPatient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable.\n\n\\-\n\nExclusion Criteria:Contraindications for thrombolysis (refer to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, intravenous thrombolysis contraindications).\n\nFemale of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.\n\nKnown history of drug (narcotics, controlled substances) abuse or addiction in the past year.\n\nHas an expected survival of less than 90 days due to concurrent malignant tumors or severe systemic diseases Incapable to comply with the protocol due to mental illness or cognitive disorder.\n\nPaticipants of any interventional drug or device clinical trials within 3 months prior to screening.\n\nUnsuitable for this study in the opinion of the investigators.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT06194968', 'briefTitle': 'Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study (TASK-UK)', 'orgStudyIdInfo': {'id': 'UK-S001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental: Urokinase', 'interventionNames': ['Drug: Urokinase']}, {'label': 'Active Comparator: Alteplase', 'interventionNames': ['Drug: Alteplase']}], 'interventions': [{'name': 'Urokinase', 'type': 'DRUG', 'description': 'administered intravenously', 'armGroupLabels': ['Experimental: Urokinase']}, {'name': 'Alteplase', 'type': 'DRUG', 'description': 'administered intravenously', 'armGroupLabels': ['Active Comparator: Alteplase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '730000', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "The First People's Hospital of Lanzhou City", 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '524000', 'city': 'Zhanjiang', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Affiliated Hospital of Guangdong Medical University', 'geoPoint': {'lat': 21.23391, 'lon': 110.38749}}, {'zip': '537400', 'city': 'Beiliu', 'state': 'Guangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Beiliu People's Hospital", 'geoPoint': {'lat': 22.70722, 'lon': 110.34917}}, {'zip': '546612', 'city': 'Guidong', 'state': 'Guangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Guidong People's Hospital of Guangxi zhuang Autonomous Region", 'geoPoint': {'lat': 25.4399, 'lon': 108.198}}, {'zip': '543300', 'city': 'Wuzhou', 'state': 'Guangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Tengxian People's Hospital", 'geoPoint': {'lat': 23.48054, 'lon': 111.28848}}, {'zip': '537000', 'city': 'Yulin', 'state': 'Guangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Red Cross Hospital of Yulin City', 'geoPoint': {'lat': 22.6305, 'lon': 110.14686}}, {'zip': '537099', 'city': 'Yulin', 'state': 'Guangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "The First People's Hospital of Yulin", 'geoPoint': {'lat': 22.6305, 'lon': 110.14686}}, {'zip': '57200', 'city': 'Sanya', 'state': 'Hainan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Sanya People's Hospital", 'geoPoint': {'lat': 18.25435, 'lon': 109.50947}}, {'zip': '154002', 'city': 'Jiamusi', 'state': 'Heilongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of Jiamusi University', 'geoPoint': {'lat': 46.79711, 'lon': 130.31118}}, {'zip': '455000', 'city': 'Anyang', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "The People's Hospital of Anyang City", 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'zip': '475000', 'city': 'Kaifeng', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Kaifeng Central Hospital', 'geoPoint': {'lat': 34.7986, 'lon': 114.30742}}, {'zip': '471100', 'city': 'Luoyang', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "The Second People's Hospital of Mengjin District", 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '467000', 'city': 'Pingdingshan', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Pingdingshan The Second People's Hospital", 'geoPoint': {'lat': 33.73091, 'lon': 113.31554}}, {'zip': '0371', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongli Tao, MD', 'role': 'CONTACT', 'email': 'tyl2112@126.com', 'phone': '+86-371-66278068'}, {'name': 'Yafang Xu, MD;PHD', 'role': 'CONTACT', 'email': 'yafangxu321@163.com', 'phone': '+86-371-66278067'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450053', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Huiji District People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '028000', 'city': 'Tongliao', 'state': 'Inner Mongolia', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Affiliated Hospital of Inner Mongolia Minzu University', 'geoPoint': {'lat': 43.6125, 'lon': 122.26528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Techpool Bio-Pharma Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Bo Song', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}