Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Group A Recombinant human urokinase (rhPro-UK) |
Drug: Recombinant human urokinase
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.
Other Names:
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Active Comparator: Group B Alteplase(rt-PA) |
Drug: Alteplase
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Functional handicap [90days]
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.
Secondary Outcome Measures
- Proportion of Neurological Improvement [90 days]
Proportion of patients achieving a NIHSS(national institutes of health stroke scale) ≦1 or reduction of ≥4 NIHSS points at 24 hours after treatment.
- Scores of Neurological Improvement [24 hours]
NIHSS changes from baseline at 24 hours after treatment
- Long-term Change from Baseline [90 days]
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.
- Proportion of Long-term Improvement [90 days]
Proportion of patients achieving a mRS of 0 to 2 and a Barthel Index of 75 to 100 at 90 days after treatment.
- Systemic hemorrhage [90days]
Severe systemic hemorrhage
- Symptomatic intracerebral hemorrhage [90days]
Symptomatic intracerebral hemorrhage (sICH)
- Death [7 days and 90 days]
Death
- Recurrence [7 days]
Recurrence of stroke
- Liver function [7 days]
The incidence of ALT≥3ULN in liver biochemical examination
- Renal function [7 days]
The incidence of Scr rising to 3 times or ≥ 4mg/dl more than the base value
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ischemic stroke with symptoms of neurological deficits.
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Aged 18 to 80 years(including the critical value).
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NIH Stroke Scale(NIHSS)scores of 4 to 25(including the critical value).
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Treatment within 4.5 hours after stroke onset.
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The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
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CT showed negative or signs of early infarction.
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Informed Consent Form signed by the patients or family (legal representatives) must be provided.
Exclusion Criteria:
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Patients with premorbid modified Rankin Scale (mRS) score ≥2
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CT showed multiple infarctions(low density> 1/3 cerebral hemisphere).
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Transient ischemic attack.
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Epileptic seizure after stroke.
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Intracranial tumor, arteriovenous malformation and aneurysm.
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Iatrogenic Stroke.
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Planned for thrombectomy.
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Cardioembolism and atrial fibrillation.
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Myocardial infarction history within 3 months.
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Severe cerebral trauma or stroke history within 3 months.
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Patients with systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg after anti-hypertension treatment.
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Intracranial hemorrhage or subarachnoid hemorrhage on baseline.
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Active visceral hemorrhage.
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Patients with intracerebral hemorrhage history.
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Patients with diabetic retinopathy history.
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Puncture in 1 week which can not be oppressed.
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Major surgery or severe trauma within 2 weeks.
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Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.
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Heparin treatment within 48h and increased APTT is above ULN.
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Using of oral anticoagulant drugs and PT >15s or INR >1.7.
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High risk of acute hemorrhage include platelet count<10^9/L.
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Using of thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination.
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Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.
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Pregnancy, lactating or menstrual women.
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The investigator believes that the patient is not suitable for the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Beijing Luhe Hospital,Capital Medical University | Beijing | Beijing | China | |
2 | XuanWu Hospital, Capital Medical University | Beijing | Beijing | China | |
3 | Liuzhou Worker's Hospital | Liuzhou | Guangxi | China | |
4 | Cangzhou Central Hospital | Cangzhou | Hebei | China | |
5 | The First Hospital of Handan | Handan | Hebei | China | |
6 | Harrison International Peace Hospital | Hengshui | Hebei | China | |
7 | The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | China | |
8 | The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China | |
9 | Tangshan Gongren Hospital | Tangshan | Hebei | China | |
10 | Daqing Oilfield General Hospital | Daqing | Heilongjiang | China | |
11 | The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China | |
12 | The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | China | |
13 | The First Hospital of Changsha | Changsha | Hunan | China | |
14 | First Affiliated Hospital of Baotou Medical College | Baotou | Inner Mongolia | China | 100053 |
15 | Baotou Central Hospital | Baotou | Inner Mongolia | China | |
16 | Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | China | |
17 | Inner Mongolia People's Hospital | Hohhot | Inner Mongolia | China | |
18 | Huai'an First People's Hospital | Huai'an | Jiangsu | China | |
19 | The Second People'Hospital of Huai'an | Huai'an | Jiangsu | China | |
20 | Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China | |
21 | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | China | |
22 | Xuzhou Central Hospital | Xuzhou | Jiangsu | China | |
23 | Jiangxi Pingxiang People's Hospital | Pingxiang | Jiangxi | China | |
24 | First Hospital of Jilin University | Changchun | Jilin | China | |
25 | The Neuropsychiatric Hospital of Jilin Province | Siping | Jilin | China | |
26 | Dalian Municipal Central Hospital | Dalian | Liaoning | China | |
27 | Shenyang Military Region General Hospital | Shenyang | Liaoning | China | |
28 | The 163th Hospital of the Chinese People's Liberation Army | Shenyang | Liaoning | China | |
29 | Liaocheng People's Hospital | Liaocheng | Shandong | China | |
30 | The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shanxi | China | |
31 | The People's Hospital of Sichuan Province | Chengdu | Sichuan | China | |
32 | Deyang people's hospital | Deyang | Sichuan | China | |
33 | Tianjin Huanhu Hospital | Tianjin | Tianjin | China | |
34 | Taizhou Hospital of Zhejiang Province | Taizhou | Zhejiang | China | |
35 | Luoyang Central Hospital | Luoyang | Zhengzhou | China |
Sponsors and Collaborators
- Tasly Biopharmaceuticals Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TASLY-B1440-CTP-Ⅲa