ProUrokinase for Mild Ischemic Cerebrovascular Events (PUMICE)
PUMICE
Recombinant Human Prourokinase（rhPro-UK）for Injection Versus Standard Medical Treatment for Acute Mild Ischemic Stroke (NIHSS≤5) Within 4.5 Hours After Symptom Onset
1 other identifier
interventional
1,446
1 country
89
Brief Summary
The purpose of this study is to investigate the safety and efficacy of rhPro-UK (35mg) versus standard medical treatment in acute mild ischemic stroke within 4.5 hours of symptom onset.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2022
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 19, 2022
CompletedStudy Start
First participant enrolled
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2024
CompletedSeptember 5, 2024
July 1, 2024
1.4 years
August 17, 2022
August 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The modified Rankin Scale score (mRS) ≤ 1 at 90 days
The proportion of the modified Rankin Scale score (mRS) ≤ 1 at 90 days.
90 days
Secondary Outcomes (10)
Ordinal distribution of mRS at 90 days
90 days
mRS score ≤ 2 at 90 days
90 days
Early neurological functional improvement
24 hours
Barthel index of 75-100 points at 90 days
90 days
Quality of Life (EQ-5D-5L) at 90 days
90 days
- +5 more secondary outcomes
Study Arms (2)
rhPro-UK (35mg)
EXPERIMENTALrhPro-UK: 35 mg (5 mg per vial, 7 vials in total) Dissolve 15mg (3 vials) of rhPro-UK in 10ml of saline and intravenous bolus within 3 minutes, and dissolve the remaining 20mg (4 vials) in 90ml of saline and intravenous drip within 30 minutes. (Note: after adding saline, overturn it gently once to twice, do not shake vigorously, so as to avoid foaming of the rhPro-UK solution and reduce the efficacy).
standard medical treatment
ACTIVE COMPARATORStandard antiplatelet or anticoagulant treatment at the discretion of local investigators according to the 'Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018'.
Interventions
15mg of rhPro-UK intravenous bolus within 3 minutes, and the remaining 20mg intravenous drip within 30 minutes.
Standard antiplatelet or anticoagulant treatment at the discretion of local investigators.
Eligibility Criteria
You may qualify if:
- Age ≥18 years, any gender;
- Acute ischemic stroke symptom onset within 4.5 hours prior to enrollment; onset time refers to 'last-seen normal time';
- Pre-stroke mRS score≤ 1;
- Baseline NIHSS ≤ 5 (both included);
- Written informed consent from patients or their legally authorized representatives
You may not qualify if:
- Rapidly improving symptoms at the discretion of the investigator;
- Intended to proceed to endovascular treatment during 90 days (including mechanical thrombectomy, stent insertion or balloon expansion);
- Allergy to rhPro-UK and it's components (human albumin, mannitol);
- NIHSS consciousness score 1a \>2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or combined with other nervous/mental illness unable to cooperate or unwilling to cooperate;
- Persistent blood pressure elevation (systolic ≥180 mmHg or diastolic ≥100 mmHg), despite blood pressure lowering treatment;
- Blood glucose \<2.8 or \>22.2 mmol/L (point of care glucose testing is acceptable);
- Active internal bleeding or at high risk of bleeding, e.g.: Major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days;
- Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR \>1.7 or prothrombin time \>15 seconds; if use of any direct thrombin inhibitors or direct factor Xa inhibitors or new oral anticoagulants (NOAC) during the last 48 hours unless reversal of effect can be achieved with a reversal agent (by idarucizumab) or sensitivity laboratory test values greater than the upper limit of normal (eg, activated partial thromboplastin time (aPTT), international normalized ratio (INR), platelet count, thrombin time (TT), or appropriate factor Xa activity assay); if on any full dose heparin/heparinoid during the last 24 hours or with an elevated aPTT greater than the upper limit of normal;
- Known defect of platelet function or platelet count below 100,000/mm3 (but patients on antiplatelet agents can be included);
- Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial haemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm (except for neuroectodermal tumors, such as meningiomas), arteriovenous malformation or giant aneurysm;
- Any terminal illness such that patient would not be expected to survive more than 1 year
- Large cerebral infarction (infarct size \> 1/3 MCA territory) on CT or MRI;
- Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma);
- Pregnant women, nursing mothers, or reluctant to agree taking effective contraceptive measures during the period of trial subjects;
- Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (89)
Taihe Hospital of Traditional Chinese Medicine
Fuyang, Anhui, 236699, China
Lujiang County People's Hospital,Anhui Province
Hefei, Anhui, 231501, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
The First Hospital of Fangshan District, Beijing
Beijing, Beijing Municipality, 102499, China
Chongqing Sanbo Chang 'an Hospital
Chongqing, Chongqing Municipality, 400023, China
Dingxi People's Hospital
Dingxi, Gansu, 743099, China
Jiuquan City People's Hospital
Jiuquan, Gansu, 735099, China
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 518025, China
Heyuan People's Hospital
Heyuan, Guangdong, 517001, China
People's Hospital of Huazhou
Maoming, Guangdong, 525199, China
Wuchuan People's Hospital
Zhanjiang, Guangdong, 524557, China
Wuming Hospital of Guangxi Medical University
Nanning, Guangxi, 530199, China
The Second People's Hospital of Guiyang
Guiyang, Guizhou, 550081, China
The Second Affiliated Hospital of Guizhou Medical University
Kaili, Guizhou, 550003, China
The People's Hospital of the Qiandongnan Miao and Dong Autonomous Prefecture
Kaili, Guizhou, 556099, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 050031, China
Hebei Tang County People Hospital
Baoding, Hebei, 071030, China
Chengde Central Hospital
Chengde, Hebei, 067024, China
Long Hua Xian Yi Yuan
Chengde, Hebei, 068150, China
Fengning Manchu Autonomous County Hospital
Chengde, Hebei, 068350, China
Wei Xian Ren Min Yi Yuan
Handan, Hebei, 056899, China
The People's Hospital of Changli County
Qinhuangdao, Hebei, 066699, China
The Second Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066699, China
Xingtang People's Hospital
Shijiazhuang, Hebei, 050699, China
Yuanshi Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, 051130, China
The Second Hospital of Xinji
Shijiazhuang, Hebei, 052360, China
Xinji Hospital of T.C.M
Shijiazhuang, Hebei, 052360, China
Linxi Hospital of Kailuan General Hospital
Tangshan, Hebei, 025250, China
Luanzhou People's Hospital
Tangshan, Hebei, 063004, China
Tangshan Guye Traditional Chinese Medicine Hospital
Tangshan, Hebei, 063199, China
Tangshan Fengnan District Hospital
Tangshan, Hebei, 063399, China
Yu Tian Xian Zhong Yi Yi Yuan
Tangshan, Hebei, 064199, China
Zunhua People's Hospital
Tangshan, Hebei, 064299, China
The People's Hospital of Qianxi County
Tangshan, Hebei, 064303, China
Weixian People's Hospital
Xingtai, Hebei, 054799, China
The Greatwall Hospital
Xingtai, Hebei, 055750, China
Center Hospital·Jiamusi
Jiamusi, Heilongjiang, 154003, China
Central Hospital·Jiaozuo
Jiaozuo, Henan, 454001, China
The Second People's Hospital of Jiaozuo
Jiaozuo, Henan, 454001, China
Jiyuan Hospital of Traditional Chinese Medicine
Jiyuan, Henan, 459001, China
Luoyang First People's Hospital
Luoyang, Henan, 471002, China
Tanghe County People's Hospital
Nanyang, Henan, 473499, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
Chinese Medicine Hospital of Puyang
Puyang, Henan, 457099, China
The First People Hospital of Lingbao
Sanmenxia, Henan, 472599, China
The Shangqiu First People's Hospital
Shangqiu, Henan, 476005, China
Xiayi County People's Hospital
Shangqiu, Henan, 476499, China
The People's Hospital of Yongcheng
Shangqiu, Henan, 476699, China
People's Hospital of Xixian
Xinyang, Henan, 464399, China
Guang Shan County People's Hospital
Xinyang, Henan, 465499, China
Xinmi Hospital of T.C.M
Zhengzhou, Henan, 452370, China
Taikang Xian People's Hospital
Zhoukou, Henan, 461499, China
Liuyang Jili Hospital
Changsha, Hunan, 410399, China
Baotou City Central Hospital
Baotou, Inner Mongolia, 014040, China
Huai'an Second People's Hospital
Huai'an, Jiangsu, 223022, China
Funing People's Hospital
Yancheng, Jiangsu, 224499, China
Jilin People's Hospital
Jilin, Jilin, 132001, China
Tonghua City vascular disease Hospital and Dongchang District People's Hospital
Tonghua, Jilin, 134099, China
Meihekou Central Hospital
Tonghua, Jilin, 135099, China
Haicheng Hospital of T.C.M
Anshan, Liaoning, 114201, China
Dalian Lvshunkou District Traditional Chinese Medicine Hospital
Dalian, Liaoning, 116041, China
General Hospital of Fushun Mining Bureau of Liaoning Health Industry Group
Fushun, Liaoning, 113012, China
Huludao Center Hospital
Huludao, Liaoning, 125001, China
The Second People's Hospital of Huludao
Huludao, Liaoning, 125060, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 511436, China
Weinan Central Hospital
Weinan, Shaanxi, 714099, China
People's Hospital of Qihe County
Dezhou, Shandong, 251199, China
Ningjin People's Hospital
Dezhou, Shandong, 253499, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252001, China
Liaocheng Third People's Hospital
Liaocheng, Shandong, 252006, China
Guanxian People's Hospital
Liaocheng, Shandong, 252599, China
The People's Hospital of Gaotang
Liaocheng, Shandong, 252899, China
People's Hospital of Yinan
Linyi, Shandong, 276399, China
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271099, China
Weihai Central Hospital
Weihai, Shandong, 264400, China
Weihai Wendeng District People's Hospital
Weihai, Shandong, 264499, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Yantai Taocun Central Hospital
Yantai, Shandong, 265301, China
Qixia Traditional Chinese Medicine Hospital
Yantai, Shandong, 265399, China
Zibo Central Hospital
Zibo, Shandong, 255020, China
Zibo Municipal Hospital
Zibo, Shandong, 255499, China
Shanghai Putuo Liqun Hospital
Shanghai, Shanghai Municipality, 200333, China
Linfen Central Hospital
Linfen, Shanxi, 041099, China
Yangquan Coal Industry(Group) General Hospital
Yangquan, Shanxi, 045008, China
Yangquan First People's Hospital
Yangquan, Shanxi, 045099, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637002, China
People's Hospital of Yilong County
Nanchong, Sichuan, 637699, China
Suining Central Hospital
Suining, Sichuan, 629099, China
Tianjin 4th Center Hospital
Tianjin, Tianjin Municipality, 300142, China
Related Publications (2)
Xiong Y, Meng X, Jin A, Campbell BCV, Xu A, Dong Q, Xu Y, Pan Y, Jiang Y, Niu S, Li Z, Zhuang X, Guo N, Yuan Z, Kong Z, Zong L, Duan C, Cao Z, Wang L, Hao M, Wu S, Feng X, Li H, Wu N, Li Z, Zhao X, Wang Y; PUMICE Investigators. Prourokinase vs Standard Care for Patients With Mild Ischemic Stroke: The PUMICE Randomized Clinical Trial. JAMA Neurol. 2025 Mar 1;82(3):258-266. doi: 10.1001/jamaneurol.2024.4688.
PMID: 39836393DERIVEDXiong Y, Hao M, Pan Y, Duan C, Feng X, Li H, Wu N, Wang L, Meng X, Zhao X, Wang Y; PUMICE investigators*. Rationale and design of ProUrokinase in Mild IsChemic strokE (PUMICE): a multicentre, prospective, randomised, open-label, blinded-endpoint controlled trial. Stroke Vasc Neurol. 2024 Dec 30;9(6):715-722. doi: 10.1136/svn-2023-002673.
PMID: 38296588DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongjun Wang, MD
Beijing Tiantan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- blinded-endpoint
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
August 17, 2022
First Posted
August 19, 2022
Study Start
November 15, 2022
Primary Completion
March 26, 2024
Study Completion
June 17, 2024
Last Updated
September 5, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share