rhPro-UK in Acute Ischaemic Stroke Within 4.5 Hours of Stroke Onset Trial 2(PROST-2)
PROST-2
A Phase III Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset
1 other identifier
interventional
1,552
1 country
72
Brief Summary
Intravenous thrombolysis is the first-line therapy in patients with acute ischemic stroke within 4·5 hours of symptom onset, and recombinant tissue plasminogen activator (alteplase) is the preferred thrombolytic agent for this purpose. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2023
Shorter than P25 for phase_3
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2023
CompletedFirst Posted
Study publicly available on registry
January 26, 2023
CompletedStudy Start
First participant enrolled
January 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2024
CompletedJuly 26, 2024
July 1, 2024
1.1 years
January 17, 2023
July 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of patients with excellent functional outcome at 90 days
A score of 0 or 1 on the modified Rankin scale(which ranges from 0 \[no symptoms\] to 6 \[death\]) at 90 days indicated an excellent functional outcome.
90±7 days
Secondary Outcomes (13)
The proportion of patients with independent functional outcome at 90 days
90±7 days
Functional handicap
90±7 days
The proportion of patients with neurological improvement at 24 hours
22-36 hours
The proportion of patients with neurological improvement at 7 days
7 ±2 days
The change of neurological function at 24 hours
22-36 hours
- +8 more secondary outcomes
Study Arms (2)
rhPro-UK
EXPERIMENTALRecombinant Human Pro-urokinase (rhPro-UK)
rt-PA
ACTIVE COMPARATORAlteplase(rt-PA)
Interventions
Eligibility Criteria
You may qualify if:
- Clinically diagnosed as acute ischemic stroke (according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018).
- years or older, male or female.
- NIH Stroke Scale（NIHSS）scores of 4 to 25.
- Treatment within 4.5 hours after stroke onset.
- The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
- Informed consent by patient or by patient's guardians.
You may not qualify if:
- Prestroke modified rankin scale of ≥2.
- Large areas of hypodense ischaemic changes on baseline CT（Infarction area\> 1/3 of the middle cerebral artery feeding area）.
- Intracranial hemorrhage.
- Previous history of intracranial hemorrhage.
- Severe cerebral trauma or stroke history within 3 months.
- Intracranial tumor or giant intracranial aneurysm.
- Intracranial or intraspinal surgery within the past 3 months.
- Gastrointestinal or urinary bleeding within the past 3 weeks.
- History of major surgical procedures or severe trauma within the last 2 weeks (investigator evaluation).
- Puncture in 1 week which can not be oppressed.
- Active visceral hemorrhage.
- Aortic arch dissection.
- Bacterial endocarditis or pericarditis.
- Planned for thrombectomy.
- Patients with systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg after anti-hypertension treatment.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
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
Related Publications (2)
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.
PMID: 39617030DERIVEDLi 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.
PMID: 38907679DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2023
First Posted
January 26, 2023
Study Start
January 29, 2023
Primary Completion
March 14, 2024
Study Completion
March 14, 2024
Last Updated
July 26, 2024
Record last verified: 2024-07