Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)
NCT ID: NCT03541668
Last Updated: 2020-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
674 participants
INTERVENTIONAL
2018-05-18
2020-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Recombinant human urokinase (rhPro-UK)
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.
Group B
Alteplase(rt-PA)
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged 18 to 80 years（including the critical value）.
3. NIH Stroke Scale（NIHSS）scores of 4 to 25（including the critical value）.
4. Treatment within 4.5 hours after stroke onset.
5. The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
6. CT showed negative or signs of early infarction.
7. Informed Consent Form signed by the patients or family (legal representatives) must be provided.
Exclusion Criteria
2. CT showed multiple infarctions（low density\> 1/3 cerebral hemisphere）.
3. Transient ischemic attack.
4. Epileptic seizure after stroke.
5. Intracranial tumor, arteriovenous malformation and aneurysm.
6. Iatrogenic Stroke.
7. Planned for thrombectomy.
8. Cardioembolism and atrial fibrillation.
9. Myocardial infarction history within 3 months.
10. Severe cerebral trauma or stroke history within 3 months.
11. Patients with systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg after anti-hypertension treatment.
12. Intracranial hemorrhage or subarachnoid hemorrhage on baseline.
13. Active visceral hemorrhage.
14. Patients with intracerebral hemorrhage history.
15. Patients with diabetic retinopathy history.
16. Puncture in 1 week which can not be oppressed.
17. Major surgery or severe trauma within 2 weeks.
18. Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.
19. Heparin treatment within 48h and increased APTT is above ULN.
20. Using of oral anticoagulant drugs and PT \>15s or INR \>1.7.
21. High risk of acute hemorrhage include platelet count\<10\^9/L.
22. Using of thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination.
23. Blood glucose \< 2.7 mmol/L or \> 22.2 mmol/L.
24. Pregnancy, lactating or menstrual women.
25. The investigator believes that the patient is not suitable for the study.
18 Years
80 Years
ALL
No
Sponsors
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Tasly Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Luhe Hospital,Capital Medical University
Beijing, Beijing Municipality, China
XuanWu Hospital, Capital Medical University
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, 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
Countries
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References
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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.
Other Identifiers
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TASLY-B1440-CTP-Ⅲa
Identifier Type: -
Identifier Source: org_study_id
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