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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Recombinant human urokinase (rhPro-UK) |
|
| Group B | Active Comparator | Alteplase(rt-PA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human urokinase | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional handicap | Proportion of patients achieving a Modified Rankin Scale(mRS,which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death) of 0 to 1 at 90 days after treatment. | 90days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Neurological Improvement | Proportion of patients achieving a NIHSS(national institutes of health stroke scale) ≦1 or reduction of ≥4 NIHSS points at 24 hours after treatment. | 90 days |
| Scores of Neurological Improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Luhe Hospital,Capital Medical University | Beijing | Beijing Municipality | China | |||
| XuanWu Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38907679 | Derived | Li S, Gu HQ, Feng B, Dong Q, Fan D, Xu Y, Zhu S, Wang Y. RhPro-UK in acute ischemic stroke within 4.5 h of stroke onset trial-2 (the PROST-2 study): Rationale and design of a multicenter, prospective, randomized, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial. Int J Stroke. 2024 Dec;19(10):1182-1187. doi: 10.1177/17474930241265654. Epub 2024 Aug 3. | |
| 37490291 |
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|
| Alteplase | Drug | 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. |
|
|
NIHSS changes from baseline at 24 hours after treatment
| 24 hours |
| Long-term Change from Baseline | NIHSS, mRS and Barthel Index(which assesses the ability to perform activities of daily living, on a scale that ranges from 0 to 100) changes from baseline on 90 days after treatment. | 90 days |
| Proportion of Long-term Improvement | Proportion of patients achieving a mRS of 0 to 2 and a Barthel Index of 75 to 100 at 90 days after treatment. | 90 days |
| Systemic hemorrhage | Severe systemic hemorrhage | 90days |
| Symptomatic intracerebral hemorrhage | Symptomatic intracerebral hemorrhage (sICH) | 90days |
| Death | Death | 7 days and 90 days |
| Recurrence | Recurrence of stroke | 7 days |
| Liver function | The incidence of ALT≥3ULN in liver biochemical examination | 7 days |
| Renal function | The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value | 7 days |
| Beijing |
| Beijing Municipality |
| China |
| Liuzhou Worker's Hospital | Liuzhou | Guangxi | China |
| Cangzhou Central Hospital | Cangzhou | Hebei | China |
| The First Hospital of Handan | Handan | Hebei | China |
| Harrison International Peace Hospital | Hengshui | Hebei | China |
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| Tangshan Gongren Hospital | Tangshan | Hebei | China |
| Daqing Oilfield General Hospital | Daqing | Heilongjiang | China |
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| The First Hospital of Changsha | Changsha | Hunan | China |
| First Affiliated Hospital of Baotou Medical College | Baotou | Inner Mongolia | 100053 | China |
| Baotou Central Hospital | Baotou | Inner Mongolia | China |
| Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | China |
| Inner Mongolia People's Hospital | Hohhot | Inner Mongolia | China |
| Huai'an First People's Hospital | Huai'an | Jiangsu | China |
| The Second People'Hospital of Huai'an | Huai'an | Jiangsu | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | China |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | China |
| Jiangxi Pingxiang People's Hospital | Pingxiang | Jiangxi | China |
| First Hospital of Jilin University | Changchun | Jilin | China |
| The Neuropsychiatric Hospital of Jilin Province | Siping | Jilin | China |
| Dalian Municipal Central Hospital | Dalian | Liaoning | China |
| Shenyang Military Region General Hospital | Shenyang | Liaoning | China |
| The 163th Hospital of the Chinese People's Liberation Army | Shenyang | Liaoning | China |
| Liaocheng People's Hospital | Liaocheng | Shandong | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | China |
| The People's Hospital of Sichuan Province | Chengdu | Sichuan | China |
| Deyang people's hospital | Deyang | Sichuan | China |
| Tianjin Huanhu Hospital | Tianjin | Tianjin Municipality | China |
| Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | China |
| Luoyang Central Hospital | Luoyang | Zhengzhou | China |
| Derived |
| Song H, Wang Y, Ma Q, Feng W, Liu R, Lv X, Huang L, Li Y, Yang Y, Geng D, Zhu J, Wei Y, Chen H, Zhu R, Zhai Q, Guo J, Liu B, Zhao S, Wang Y; PROST collaborative group. 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. |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
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