AzTrials
AzTrials

Ischemic StrokePhase 3PUMICENCT05507645

ProUrokinase for Mild Ischemic Cerebrovascular Events (PUMICE)

A Phase 3 study testing Recombinant Human Prourokinase for Injection (rhPro-UK) and standard medical treatment in people with Ischemic Stroke and Mild, run by Beijing Tiantan Hospital at 89 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Mild, Thrombosis
What is being tested?
Recombinant Human Prourokinase for Injection (rhPro-UK) and standard medical treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,446 participants
Where
89 sitesChina
Study dates
15 Nov 2022to 17 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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);
Show all 16Show fewer
  • 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;
  • Participation in other interventional clinical trials within the previous 3 months.

Trial locations and contacts

89 sites in 1 country.

89 sites in 1 country

China89 sites

  • Haicheng Hospital of T.C.M

    Anshan, Liaoning, 114201

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 050031

  • Hebei Tang County People Hospital

    Baoding, Hebei, 071030

  • Baotou City Central Hospital

    Baotou, Inner Mongolia, 014040

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

  • The First Hospital of Fangshan District, Beijing

    Beijing, Beijing Municipality, 102499

  • Liuyang Jili Hospital

    Changsha, Hunan, 410399

  • Chengde Central Hospital

    Chengde, Hebei, 067024

  • Long Hua Xian Yi Yuan

    Chengde, Hebei, 068150

  • Fengning Manchu Autonomous County Hospital

    Chengde, Hebei, 068350

  • Chongqing Sanbo Chang 'an Hospital

    Chongqing, Chongqing Municipality, 400023

  • Dalian Lvshunkou District Traditional Chinese Medicine Hospital

    Dalian, Liaoning, 116041

  • People's Hospital of Qihe County

    Dezhou, Shandong, 251199

  • Ningjin People's Hospital

    Dezhou, Shandong, 253499

  • Dingxi People's Hospital

    Dingxi, Gansu, 743099

  • General Hospital of Fushun Mining Bureau of Liaoning Health Industry Group

    Fushun, Liaoning, 113012

  • Taihe Hospital of Traditional Chinese Medicine

    Fuyang, Anhui, 236699

  • Guangdong Second Provincial General Hospital

    Guangzhou, Guangdong, 518025

  • The Second People's Hospital of Guiyang

    Guiyang, Guizhou, 550081

  • Wei Xian Ren Min Yi Yuan

    Handan, Hebei, 056899

  • Lujiang County People's Hospital,Anhui Province

    Hefei, Anhui, 231501

  • Heyuan People's Hospital

    Heyuan, Guangdong, 517001

  • Huai'an Second People's Hospital

    Huai'an, Jiangsu, 223022

  • Huludao Center Hospital

    Huludao, Liaoning, 125001

  • The Second People's Hospital of Huludao

    Huludao, Liaoning, 125060

  • Center Hospital·Jiamusi

    Jiamusi, Heilongjiang, 154003

  • Central Hospital·Jiaozuo

    Jiaozuo, Henan, 454001

  • The Second People's Hospital of Jiaozuo

    Jiaozuo, Henan, 454001

  • Jilin People's Hospital

    Jilin City, Jilin, 132001

  • Jiuquan City People's Hospital

    Jiuquan, Gansu, 735099

  • Jiyuan Hospital of Traditional Chinese Medicine

    Jiyuan, Henan, 459001

  • The Second Affiliated Hospital of Guizhou Medical University

    Kaili, Guizhou, 550003

  • The People's Hospital of the Qiandongnan Miao and Dong Autonomous Prefecture

    Kaili, Guizhou, 556099

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252001

  • Liaocheng Third People's Hospital

    Liaocheng, Shandong, 252006

  • Guanxian People's Hospital

    Liaocheng, Shandong, 252599

  • The People's Hospital of Gaotang

    Liaocheng, Shandong, 252899

  • Linfen Central Hospital

    Linfen, Shanxi, 041099

  • People's Hospital of Yinan

    Linyi, Shandong, 276399

  • Luoyang First People's Hospital

    Luoyang, Henan, 471002

  • People's Hospital of Huazhou

    Maoming, Guangdong, 525199

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637002

  • People's Hospital of Yilong County

    Nanchong, Sichuan, 637699

  • Wuming Hospital of Guangxi Medical University

    Nanning, Guangxi, 530199

  • Tanghe County People's Hospital

    Nanyang, Henan, 473499

  • Puyang Oilfield General Hospital

    Puyang, Henan, 457001

  • Chinese Medicine Hospital of Puyang

    Puyang, Henan, 457099

  • The People's Hospital of Changli County

    Qinhuangdao, Hebei, 066699

  • The Second Hospital of Qinhuangdao

    Qinhuangdao, Hebei, 066699

  • The First People Hospital of Lingbao

    Sanmenxia, Henan, 472599

  • Shanghai Putuo Liqun Hospital

    Shanghai, Shanghai Municipality, 200333

  • The Shangqiu First People's Hospital

    Shangqiu, Henan, 476005

  • Xiayi County People's Hospital

    Shangqiu, Henan, 476499

  • The People's Hospital of Yongcheng

    Shangqiu, Henan, 476699

  • The Fourth Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 511436

  • Xingtang People's Hospital

    Shijiazhuang, Hebei, 050699

  • Yuanshi Hospital of Traditional Chinese Medicine

    Shijiazhuang, Hebei, 051130

  • The Second Hospital of Xinji

    Shijiazhuang, Hebei, 052360

  • Xinji Hospital of T.C.M

    Shijiazhuang, Hebei, 052360

  • Suining Central Hospital

    Suining, Sichuan, 629099

  • The Second Affiliated Hospital of Shandong First Medical University

    Tai’an, Shandong, 271099

  • Linxi Hospital of Kailuan General Hospital

    Tangshan, Hebei, 025250

  • Luanzhou People's Hospital

    Tangshan, Hebei, 063004

  • Tangshan Guye Traditional Chinese Medicine Hospital

    Tangshan, Hebei, 063199

  • Tangshan Fengnan District Hospital

    Tangshan, Hebei, 063399

  • Yu Tian Xian Zhong Yi Yi Yuan

    Tangshan, Hebei, 064199

  • Zunhua People's Hospital

    Tangshan, Hebei, 064299

  • The People's Hospital of Qianxi County

    Tangshan, Hebei, 064303

  • Tianjin 4th Center Hospital

    Tianjin, Tianjin Municipality, 300142

  • Tonghua City vascular disease Hospital and Dongchang District People's Hospital

    Tonghua, Jilin, 134099

  • Meihekou Central Hospital

    Tonghua, Jilin, 135099

  • Weihai Central Hospital

    Weihai, Shandong, 264400

  • Weihai Wendeng District People's Hospital

    Weihai, Shandong, 264499

  • Weinan Central Hospital

    Weinan, Shaanxi, 714099

  • Weixian People's Hospital

    Xingtai, Hebei, 054799

  • The Greatwall Hospital

    Xingtai, Hebei, 055750

  • People's Hospital of Xixian

    Xinyang, Henan, 464399

  • Guang Shan County People's Hospital

    Xinyang, Henan, 465499

  • Funing People's Hospital

    Yancheng, Jiangsu, 224499

  • Yangquan Coal Industry(Group) General Hospital

    Yangquan, Shanxi, 045008

  • Yangquan First People's Hospital

    Yangquan, Shanxi, 045099

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

  • Yantai Taocun Central Hospital

    Yantai, Shandong, 265301

  • Qixia Traditional Chinese Medicine Hospital

    Yantai, Shandong, 265399

  • Wuchuan People's Hospital

    Zhanjiang, Guangdong, 524557

  • Xinmi Hospital of T.C.M

    Zhengzhou, Henan, 452370

  • Taikang Xian People's Hospital

    Zhoukou, Henan, 461499

  • Zibo Central Hospital

    Zibo, Shandong, 255020

  • Zibo Municipal Hospital

    Zibo, Shandong, 255499

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

After being informed about the study and potential risks, patients who meet the eligibility requirements will be randomized to recombinant human Prourokinase for injection (rhPro-UK) or standard medical treatment in a 1:1 ratio. Written informed consent will be needed.

Being tested
Recombinant Human Prourokinase for Injection (rhPro-UK), standard medical treatment
Medical subject headings
Ischemic Stroke, Lymphoma, Follicular, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant Human Prourokinase for Injection (rhPro-UK)Drug

    Also called Puyouke

    15mg of rhPro-UK intravenous bolus within 3 minutes, and the remaining 20mg intravenous drip within 30 minutes.

  • standard medical treatmentDrug

    Also called Aspirin, clopidogrel, anticoagulant

    Standard antiplatelet or anticoagulant treatment at the discretion of local investigators.

Study groups in NCT05507645
Study groupRoleWhat they receive
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).
Receives: Drug: Recombinant Human Prourokinase for Injection (rhPro-UK)
standard medical treatmentActive 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'.
Receives: Drug: standard medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The modified Rankin Scale score (mRS) ≤ 1 at 90 days

    The proportion of the modified Rankin Scale score (mRS) ≤ 1 at 90 days.

    Measured: 90 days

Secondary outcomes (10)

  1. Ordinal distribution of mRS at 90 days

    Ordinal distribution of mRS at 90 days

    Measured: 90 days

  2. mRS score ≤ 2 at 90 days

    The proportion of mRS score ≤ 2 at 90 days

    Measured: 90 days

  3. Early neurological functional improvement

    Clinical response rate at 24 hours defined as an improvement on NIHSS score ≥ 4 points compared with the initial deficit or NIHSS score ≤ 1 point

    Measured: 24 hours

  4. Barthel index of 75-100 points at 90 days

    The proportion of Barthel index of 75-100 points at 90 days

    Measured: 90 days

  5. Quality of Life (EQ-5D-5L) at 90 days

    The value of Quality of Life (EQ-5D-5L) at 90 days

    Measured: 90 days

  6. Activities of Daily Living (Lawton IADL) at 90 days

    The score of Activities of Daily Living (Lawton IADL) at 90 days

    Measured: 90 days

  7. Symptomatic intracranial hemorrhage within 36 hours

    The rate of symptomatic intracranial hemorrhage within 36 hours (as defined by ECASS III)

    Measured: 36 hours

  8. All-cause death at 90 days

    All-cause mortality at 90 days

    Measured: 90 days

  9. Systematic bleeding at 90 days

    The rate of systematic bleeding at 90 days (as defined by GUSTO: moderate and severe bleeding)

    Measured: 90 days

  10. Adverse events (AEs)/ serious adverse events (SAEs) within 90 days

    The proportion of AEs/SAEs within 90 days

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start15 Nov 2022
  3. Primary completion26 Mar 2024
  4. Study completion17 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05507645
Sponsor's protocol ID
HX-A-2022032
Acronym
PUMICE
Status last verified
Jul 2024
First submitted
17 Aug 2022
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39836393

  • Xiong 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.

    PubMed 38296588

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant Human Prourokinase for Injection (rhPro-UK) and standard medical treatment in people with Ischemic Stroke and Mild, run by Beijing Tiantan Hospital at 89 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The modified Rankin Scale score (mRS) ≤ 1 at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05507645, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.

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