Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
Study NCT ID:
NCT03541668
Status:
COMPLETED
Last Update Posted:
2020-06-22
First Post:
2018-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)
Sponsor:
Organization:
Raw JSON
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Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Ischemic Stroke Within 4.5 Hours of Stroke Onset: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2325415. doi: 10.1001/jamanetworkopen.2023.25415.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, rt-PA controlled, open-label phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus rt-PA thrombolysis for patients with acute ischaemic stroke in 4.5 hours after stroke onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ischemic stroke with symptoms of neurological deficits.\n2. Aged 18 to 80 years（including the critical value）.\n3. NIH Stroke Scale（NIHSS）scores of 4 to 25（including the critical value）.\n4. Treatment within 4.5 hours after stroke onset.\n5. The symptoms of stroke last at least 30 minutes without significant improvement before treatment.\n6. CT showed negative or signs of early infarction.\n7. Informed Consent Form signed by the patients or family (legal representatives) must be provided.\n\nExclusion Criteria:\n\n1. Patients with premorbid modified Rankin Scale (mRS) score ≥2\n2. CT showed multiple infarctions（low density\\> 1/3 cerebral hemisphere）.\n3. Transient ischemic attack.\n4. Epileptic seizure after stroke.\n5. Intracranial tumor, arteriovenous malformation and aneurysm.\n6. Iatrogenic Stroke.\n7. Planned for thrombectomy.\n8. Cardioembolism and atrial fibrillation.\n9. Myocardial infarction history within 3 months.\n10. Severe cerebral trauma or stroke history within 3 months.\n11. Patients with systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg after anti-hypertension treatment.\n12. Intracranial hemorrhage or subarachnoid hemorrhage on baseline.\n13. Active visceral hemorrhage.\n14. Patients with intracerebral hemorrhage history.\n15. Patients with diabetic retinopathy history.\n16. Puncture in 1 week which can not be oppressed.\n17. Major surgery or severe trauma within 2 weeks.\n18. Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.\n19. Heparin treatment within 48h and increased APTT is above ULN.\n20. Using of oral anticoagulant drugs and PT \\>15s or INR \\>1.7.\n21. High risk of acute hemorrhage include platelet count\\<10\\^9/L.\n22. Using of thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination.\n23. Blood glucose \\< 2.7 mmol/L or \\> 22.2 mmol/L.\n24. Pregnancy, lactating or menstrual women.\n25. The investigator believes that the patient is not suitable for the study.'}, 'identificationModule': {'nctId': 'NCT03541668', 'briefTitle': 'Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tasly Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Phase III Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset', 'orgStudyIdInfo': {'id': 'TASLY-B1440-CTP-Ⅲa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Recombinant human urokinase (rhPro-UK)', 'interventionNames': ['Drug: Recombinant human urokinase']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Alteplase(rt-PA)', 'interventionNames': ['Drug: Alteplase']}], 'interventions': [{'name': 'Recombinant human urokinase', 'type': 'DRUG', 'otherNames': ['rhPro-UK'], 'description': 'Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3 minutes followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 minutes.', 'armGroupLabels': ['Group A']}, {'name': 'Alteplase', 'type': 'DRUG', 'otherNames': ['rt-PA'], 'description': 'Patients receive rt-PA in a dose of 0.9mg per kilogram of body weight(maximum,90 mg),10 percent of which was given as a blous followed by delivery of the remaining 90 percent as a constant infusion over a period of 60 minutes.', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Luhe Hospital,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'XuanWu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Liuchow', 'state': 'Guangxi', 'country': 'China', 'facility': "Liuzhou Worker's Hospital", 'geoPoint': {'lat': 24.32405, 'lon': 109.40698}}, {'city': 'Cangzhou', 'state': 'Hebei', 'country': 'China', 'facility': 'Cangzhou Central Hospital', 'geoPoint': {'lat': 38.31124, 'lon': 116.85334}}, {'city': 'Handan', 'state': 'Hebei', 'country': 'China', 'facility': 'The First Hospital of Handan', 'geoPoint': {'lat': 36.60999, 'lon': 114.48764}}, {'city': 'Hengshui', 'state': 'Hebei', 'country': 'China', 'facility': 'Harrison International Peace Hospital', 'geoPoint': {'lat': 37.73908, 'lon': 115.68348}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Tangshan', 'state': 'Hebei', 'country': 'China', 'facility': 'Tangshan Gongren Hospital', 'geoPoint': {'lat': 39.64381, 'lon': 118.18319}}, {'city': 'Daqing', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Daqing Oilfield General Hospital', 'geoPoint': {'lat': 46.58333, 'lon': 125.0}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The Fourth Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The First Hospital of Changsha', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '100053', 'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'First Affiliated Hospital of Baotou Medical College', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'city': 'Baotou', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Baotou Central Hospital', 'geoPoint': {'lat': 40.6516, 'lon': 109.84389}}, {'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Affiliated Hospital of Inner Mongolia Medical University', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'facility': "Inner Mongolia People's Hospital", 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'city': "Huai'an", 'state': 'Jiangsu', 'country': 'China', 'facility': "Huai'an First People's Hospital", 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}, {'city': "Huai'an", 'state': 'Jiangsu', 'country': 'China', 'facility': "The Second People'Hospital of Huai'an", 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Xuzhou Central Hospital', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'city': 'Pingxiang', 'state': 'Jiangxi', 'country': 'China', 'facility': "Jiangxi Pingxiang People's Hospital", 'geoPoint': {'lat': 27.61672, 'lon': 113.85353}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Siping', 'state': 'Jilin', 'country': 'China', 'facility': 'The Neuropsychiatric Hospital of Jilin Province', 'geoPoint': {'lat': 43.16143, 'lon': 124.37785}}, {'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'Dalian Municipal Central Hospital', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shenyang Military Region General Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': "The 163th Hospital of the Chinese People's Liberation Army", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Liaocheng', 'state': 'Shandong', 'country': 'China', 'facility': "Liaocheng People's Hospital", 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "The People's Hospital of Sichuan Province", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Deyang', 'state': 'Sichuan', 'country': 'China', 'facility': "Deyang people's hospital", 'geoPoint': {'lat': 31.13019, 'lon': 104.38198}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Huanhu Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Taizhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Taizhou Hospital of Zhejiang Province', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}, {'city': 'Luoyang', 'state': 'Zhengzhou', 'country': 'China', 'facility': 'Luoyang Central Hospital', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tasly Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}