rhPro-UK in Acute Ischaemic Stroke Within 4.5 Hours of Stroke Onset Trial 2(PROST-2)
NCT ID: NCT05700591
Last Updated: 2024-07-26
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1552 participants
INTERVENTIONAL
2023-01-29
2024-03-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
RhPro-UK is a specific plasminogen activator. rhPro-UK only acts on occlusive thrombus and has little effect on hemostatic thrombus. In addition, rhPro-UK does not form covalent complexes with protease inhibitors in plasma, so the concentrations of rhpro-UK and protease inhibitors in the blood do not decrease compared with alteplase. Therefore, rhPro-UK therapies have a potential advantage of less systemic bleeding in treated subjects. Data from several previous studies suggest that rhPro-UK is efficacious when used to treat patients with acute myocardial infarction. On April 2, 2011, rhPro-UK injection was approved by the National Medical Products Administration to treat acute myocardial infarction. Since then, rhPro-UK has been widely used to treat myocardial infarction in China.
Since 2016, a phase 2 clinical trial was carried to explore the dosing of rhPro-UK in patients with acute ischemic stroke, followed by another study with a sample size of 680 patients to initially validate the efficacy and safety of the proposed dose of 35mg. The results of these studies suggested that rhPro-UK was effective, and there were no safety concerns. To further prove the efficacy and safety of rhPro-UK in patients with acute ischemic stroke, investigators conducted this phase 3 study (PROST-2).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of rhPro-UK in Patients With Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset(PROST)
NCT03541668
Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial
NCT03578822
Intravenous Thrombolysis With rhTNK-tPA for Acute Non-large Vessel Occlusion in Extended Time Window
NCT05752916
Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-II）
NCT05281549
Thrombolysis Treated With TNK-tPA in Acute Ischemic Stroke Patients （3T Stroke-Ⅲ）
NCT05745259
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
rhPro-UK
Recombinant Human Pro-urokinase (rhPro-UK)
rhPro-UK
35 mg, administered intravenously with a bolus of 15 mg within 3 minutes and the remainder by continuous infusion within 30 minutes
rt-PA
Alteplase(rt-PA)
rt-PA
0.9 mg/kg (maximum 90 mg), with 10% administered intravenously as a bolus, followed by 90% infusion within 1 hour
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
rhPro-UK
35 mg, administered intravenously with a bolus of 15 mg within 3 minutes and the remainder by continuous infusion within 30 minutes
rt-PA
0.9 mg/kg (maximum 90 mg), with 10% administered intravenously as a bolus, followed by 90% infusion within 1 hour
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 18 years or older, male or female.
3. NIH Stroke Scale（NIHSS）scores of 4 to 25.
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. Informed consent by patient or by patient's guardians.
Exclusion Criteria
2. Large areas of hypodense ischaemic changes on baseline CT（Infarction area\> 1/3 of the middle cerebral artery feeding area）.
3. Intracranial hemorrhage.
4. Previous history of intracranial hemorrhage.
5. Severe cerebral trauma or stroke history within 3 months.
6. Intracranial tumor or giant intracranial aneurysm.
7. Intracranial or intraspinal surgery within the past 3 months.
8. Gastrointestinal or urinary bleeding within the past 3 weeks.
9. History of major surgical procedures or severe trauma within the last 2 weeks (investigator evaluation).
10. Puncture in 1 week which can not be oppressed.
11. Active visceral hemorrhage.
12. Aortic arch dissection.
13. Bacterial endocarditis or pericarditis.
14. Planned for thrombectomy.
15. Patients with systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg after anti-hypertension treatment.
16. High risk of acute hemorrhage include platelet count\<10\^9/L.
17. Received low molecular weight heparin or heparin within 24 hours.
18. Using of thrombin inhibitors or factor Xa inhibitor within the past 48 hours.
19. Using of oral anticoagulant drugs and PT \>15s or INR \>1.7.
20. Patients with epilepsy or other mental disorders that could not be adhered to at the beginning of stroke.
21. Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L.
22. Allergies to rhPro-UK or rt-PA active ingredients or other components.
23. Pregnant women or beastfeeding women.
24. Participants in other clinical trials within the past month.
25. The investigator believes that the patient is not suitable for the study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tasly Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xuancheng People's Hospital
Xuancheng, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Huizhou First Hospital
Guangdong, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Handan Central Hospital
Handan, Hebei, China
Hengshui People's Hospital (Harrison International Peace Hospital)
Hengshui, Hebei, China
Hebei General Hospital
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Daqing People's Hospital
Daqing, Heilongjiang, China
Anyang People's Hospital
Anyang, Henan, China
Luoyang Central Hospital
Luoyang, Henan, China
First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Nanshi Hospital of Nanyang
Nanyang, Henan, China
Nanyang Second General Hospital
Nanyang, Henan, China
General Hospital of Pingmei Shenma Medical Group
Pingdingshan, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
Zhumadian Central Hospital
Zhumadian, Henan, China
Tongji Hospital affiliated to Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan Fourth Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Baogang Hospital of Inner Mongolia
Baotou, Inner Mongolia, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science & Technology
Baotou, Inner Mongolia, China
Keshiketeng Hospital of Traditional Chinese Medicine and Mongolian Medicine
Chifeng, Inner Mongolia, China
The Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia, China
Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
General Hospital of Xuzhou Coal Mining Group
Xuzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, China
Jilin Guowen Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Meihekou Central Hospital
Meihekou, Jilin, China
Jilin Neuropsychiatric Hospital
Siping, Jilin, China
Tonghua Central Hospital
Tonghua, Jilin, China
Ansteel Group General Hospital
Anshan, Liaoning, China
Benxi Central Hospital
Benxi, Liaoning, China
Beipiao Central Hospital
Chaoyang, Liaoning, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
Fukuang General Hospital of Liaoning Health Industry Group
Fushun, Liaoning, China
Fuxinkuang General Hospital of Liaoning Health Industry Group
Fuxin, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, China
The First People's Hospital of Shenyang
Shenyang, Liaoning, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
The PLA General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Xianyang Hospital Of Yan'an University
Xianyang, Shaanxi, China
Dezhou People's Hospital
Dezhou, Shandong, China
Tengzhou Central People's Hospital
Dezhou, Shandong, China
Shengli Oilfield Central Hospital
Dongying, Shandong, China
Jinan City People's Hospital
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Linyi People's Hospital
Linyi, Shandong, China
Tai'an Central Hospital
Tai’an, Shandong, China
First People's Hospital of Tancheng
Tancheng, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Sinopharm Tongmei General Hospital
Datong, Shanxi, China
Linfen Central Hospital
Linfen, Shanxi, China
Linfen People's Hospital
Linfen, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Taizhou First People's Hospital
Taizhou, Zhejiang, China
Zhejiang Taizhou Hospital
Taizhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Li S, Gu HQ, Feng B, Li H, Wang X, Dong Q, Fan D, Xu Y, Zhu S, Dai H, Wei Y, Wang Z, Lu G, Ma Y, Li Z, Wang Y, Meng X, Zhao X, Liu L, Wang Y; PROST-2 investigators. Safety and efficacy of intravenous recombinant human prourokinase for acute ischaemic stroke within 4.5 h after stroke onset (PROST-2): a phase 3, open-label, non-inferiority, randomised controlled trial. Lancet Neurol. 2025 Jan;24(1):33-41. doi: 10.1016/S1474-4422(24)00436-8. Epub 2024 Nov 29.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TASLY-B1440-CTP-Ⅲc
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.