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This is a randomized,controlled, double-blinded, phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus basic treatment for patients with acute ischaemic stroke in 4.5-6 hours after stroke onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Recombinant human urokinase(rhPro-UK) and Aspirin simulation agent |
|
| Group B | Other | rhPro-UK simulation agent and Aspirn |
|
| 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 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min. |
| 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 |
|---|---|---|---|---|---|---|
| XuanWu Hospital, Capital Medical University | Beijing | Beijing Municipality | China | |||
| Harrison International Peace Hospital |
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|
| Aspirin | Drug | Aspirin 300mg is taken orally at the beginning of thrombolysis. |
|
| rhPro-UK simulation agent | Drug | Patients receive rhPro-UK simulation agent 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min. |
|
| Aspirin simulation agent | Drug | Aspirin simulation agent 300mg is taken orally at the beginning of thrombolysis. |
|
NIHSS changes from baseline at 24 hours after treatment
| 24 hours |
| Index Long-term Change from Baseline of Barthel Index | 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 |
| Long-term Change from Baseline of NIHSS | NIHSS changes from baseline on 90 days after treatment. | 90 days |
| Long-term Change from Baseline of mRS | mRS 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 at 90 days after treatment. | 90 days |
| Proportion of Long-term Improvement | Proportion of patients achieving 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 |
| Hengshui |
| Hebei |
| China |
| Tangshan Gongren Hospital | Tangshan | Hebei | China |
| Baotou Central Hospital | Baotou | Inner Mongolia | China |
| First Affiliated Hospital of Baotou Medical College | 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 |
| Zhongda Hospital Southeast University | 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 |
| Meihekou Central Hospital | Meihekou | Jilin | China |
| Dalian Municipal Central Hospital | Dalian | Liaoning | China |
| Shenyang Military Region General Hospital | Shenyang | Liaoning | China |
| The First People's Hospital of Shenyang | Shenyang | Liaoning | China |
| Luoyang Central Hospital | Luoyang | Zhengzhou | China |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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