ProUrokinase for Mild Ischemic Cerebrovascular Events (PUMICE) (PUMICE)

August 31, 2024 updated by: Yongjun Wang, Beijing Tiantan Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1446

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Fuyang, Anhui, China, 236699
        • Taihe Hospital of Traditional Chinese Medicine
      • Hefei, Anhui, China, 231501
        • Lujiang County People's Hospital,Anhui Province
    • Beijing
      • Beijing, Beijing, China, 100070
        • Beijing Tiantan Hospital, Capital Medical University
      • Beijing, Beijing, China, 102499
        • The First Hospital of Fangshan District, Beijing
    • Chongqing
      • Chongqing, Chongqing, China, 400023
        • Chongqing Sanbo Chang 'an Hospital
    • Gansu
      • Dingxi, Gansu, China, 743099
        • Dingxi People's Hospital
      • Jiuquan, Gansu, China, 735099
        • Jiuquan City People's Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 518025
        • Guangdong Second Provincial General Hospital
      • Heyuan, Guangdong, China, 517001
        • Heyuan People's Hospital
      • Maoming, Guangdong, China, 525199
        • People's Hospital of Huazhou
      • Zhanjiang, Guangdong, China, 524557
        • Wuchuan People's Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530199
        • Wuming Hospital of Guangxi Medical University
    • Guizhou
      • Guiyang, Guizhou, China, 550081
        • The Second People's Hospital of Guiyang
      • Kaili, Guizhou, China, 550003
        • The Second Affiliated Hospital of Guizhou Medical University
      • Kaili, Guizhou, China, 556099
        • The People's Hospital of the Qiandongnan Miao and Dong Autonomous Prefecture
    • Hebei
      • Baoding, Hebei, China, 050031
        • Affiliated Hospital of Hebei University
      • Baoding, Hebei, China, 071030
        • Hebei Tang County People Hospital
      • Chengde, Hebei, China, 067024
        • Chengde Central Hospital
      • Chengde, Hebei, China, 068150
        • Long Hua Xian Yi Yuan
      • Chengde, Hebei, China, 068350
        • Fengning Manchu Autonomous County Hospital
      • Handan, Hebei, China, 056899
        • Wei Xian Ren Min Yi Yuan
      • Qinhuangdao, Hebei, China, 066699
        • The People's Hospital of Changli County
      • Qinhuangdao, Hebei, China, 066699
        • The second Hospital of Qinhuangdao
      • Shijiazhuang, Hebei, China, 050699
        • Xingtang People's Hospital
      • Shijiazhuang, Hebei, China, 051130
        • Yuanshi Hospital of Traditional Chinese Medicine
      • Shijiazhuang, Hebei, China, 052360
        • The Second Hospital of Xinji
      • Shijiazhuang, Hebei, China, 052360
        • Xinji Hospital of T.C.M
      • Tangshan, Hebei, China, 025250
        • Linxi Hospital of Kailuan General Hospital
      • Tangshan, Hebei, China, 063004
        • Luanzhou People's Hospital
      • Tangshan, Hebei, China, 063199
        • Tangshan Guye Traditional Chinese Medicine Hospital
      • Tangshan, Hebei, China, 063399
        • Tangshan Fengnan District Hospital
      • Tangshan, Hebei, China, 064199
        • Yu Tian Xian Zhong Yi Yi Yuan
      • Tangshan, Hebei, China, 064299
        • Zunhua People's Hospital
      • Tangshan, Hebei, China, 064303
        • The People's Hospital of Qianxi County
      • Xingtai, Hebei, China, 054799
        • Weixian People's Hospital
      • Xingtai, Hebei, China, 055750
        • The Greatwall Hospital
    • Heilongjiang
      • Jiamusi, Heilongjiang, China, 154003
        • Center Hospital·Jiamusi
    • Henan
      • Jiaozuo, Henan, China, 454001
        • Central Hospital·Jiaozuo
      • Jiaozuo, Henan, China, 454001
        • The Second People's Hospital of Jiaozuo
      • Jiyuan, Henan, China, 459001
        • Jiyuan Hospital of Traditional Chinese Medicine
      • Luoyang, Henan, China, 471002
        • Luoyang First People's Hospital
      • Nanyang, Henan, China, 473499
        • Tanghe County People's Hospital
      • Puyang, Henan, China, 457001
        • Puyang Oilfield General Hospital
      • Puyang, Henan, China, 457099
        • Chinese Medicine Hospital Of Puyang
      • Sanmenxia, Henan, China, 472599
        • The First People Hospital of Lingbao
      • Shangqiu, Henan, China, 476005
        • The Shangqiu First People's Hospital
      • Shangqiu, Henan, China, 476499
        • Xiayi County People's Hospital
      • Shangqiu, Henan, China, 476699
        • The People's Hospital of Yongcheng
      • Xinyang, Henan, China, 464399
        • People's Hospital of Xixian
      • Xinyang, Henan, China, 465499
        • Guang Shan County People's Hospital
      • Zhengzhou, Henan, China, 452370
        • Xinmi Hospital of T.C.M
      • Zhoukou, Henan, China, 461499
        • Taikang Xian People's Hospital
    • Hunan
      • Changsha, Hunan, China, 410399
        • Liuyang Jili Hospital
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014040
        • Baotou City Central Hospital
    • Jiangsu
      • Huai'an, Jiangsu, China, 223022
        • Huai'an Second People's Hospital
      • Yancheng, Jiangsu, China, 224499
        • Funing People's Hospital
    • Jilin
      • Jilin, Jilin, China, 132001
        • Jilin People's Hospital
      • Tonghua, Jilin, China, 134099
        • Tonghua City vascular disease Hospital and Dongchang District People's Hospital
      • Tonghua, Jilin, China, 135099
        • Meihekou Central Hospital
    • Liaoning
      • Anshan, Liaoning, China, 114201
        • Haicheng Hospital of T.C.M
      • Dalian, Liaoning, China, 116041
        • Dalian Lvshunkou District Traditional Chinese Medicine Hospital
      • Fushun, Liaoning, China, 113012
        • General Hospital of Fushun Mining Bureau of Liaoning Health Industry Group
      • Huludao, Liaoning, China, 125001
        • Huludao Center Hospital
      • Huludao, Liaoning, China, 125060
        • The Second People's Hospital of Huludao
      • Shenyang, Liaoning, China, 511436
        • The Fourth Affiliated Hospital of China Medical University
    • Shaanxi
      • Weinan, Shaanxi, China, 714099
        • Weinan Central Hospital
    • Shandong
      • Dezhou, Shandong, China, 251199
        • People's Hospital of Qihe County
      • Dezhou, Shandong, China, 253499
        • Ningjin People's Hospital
      • Liaocheng, Shandong, China, 252006
        • Liaocheng Third People's Hospital
      • Liaocheng, Shandong, China, 252001
        • Liaocheng People's Hospital
      • Liaocheng, Shandong, China, 252599
        • Guanxian People's Hospital
      • Liaocheng, Shandong, China, 252899
        • The People's Hospital of Gaotang
      • Linyi, Shandong, China, 276399
        • People's Hospital of Yinan
      • Tai'an, Shandong, China, 271099
        • The Second Affiliated Hospital of Shandong First Medical University
      • Weihai, Shandong, China, 264400
        • Weihai Central Hospital
      • Weihai, Shandong, China, 264499
        • Weihai Wendeng District People's Hospital
      • Yantai, Shandong, China, 264099
        • Yantai Yuhuangding Hospital
      • Yantai, Shandong, China, 265301
        • Yantai Taocun Central Hospital
      • Yantai, Shandong, China, 265399
        • Qixia traditional Chinese medicine hospital
      • Zibo, Shandong, China, 255020
        • Zibo central Hospital
      • Zibo, Shandong, China, 255499
        • Zibo Municipal Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200333
        • Shanghai Putuo Liqun Hospital
    • Shanxi
      • Linfen, Shanxi, China, 041099
        • Linfen Central Hospital
      • Yangquan, Shanxi, China, 045008
        • Yangquan coal Industry(Group) General Hospital
      • Yangquan, Shanxi, China, 045099
        • Yangquan First People's Hospital
    • Sichuan
      • Nanchong, Sichuan, China, 637002
        • Affiliated Hospital of North Sichuan Medical College
      • Nanchong, Sichuan, China, 637699
        • People's Hospital of Yilong County
      • Suining, Sichuan, China, 629099
        • Suining Central Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300142
        • Tianjin 4th Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years, any gender;
  2. Acute ischemic stroke symptom onset within 4.5 hours prior to enrollment; onset time refers to 'last-seen normal time';
  3. Pre-stroke mRS score≤ 1;
  4. Baseline NIHSS ≤ 5 (both included);
  5. Written informed consent from patients or their legally authorized representatives

Exclusion Criteria:

  1. Rapidly improving symptoms at the discretion of the investigator;
  2. Intended to proceed to endovascular treatment during 90 days (including mechanical thrombectomy, stent insertion or balloon expansion);
  3. Allergy to rhPro-UK and it's components (human albumin, mannitol);
  4. 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;
  5. Persistent blood pressure elevation (systolic ≥180 mmHg or diastolic ≥100 mmHg), despite blood pressure lowering treatment;
  6. Blood glucose <2.8 or >22.2 mmol/L (point of care glucose testing is acceptable);
  7. 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;
  8. 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;
  9. Known defect of platelet function or platelet count below 100,000/mm3 (but patients on antiplatelet agents can be included);
  10. 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;
  11. Any terminal illness such that patient would not be expected to survive more than 1 year
  12. Large cerebral infarction (infarct size > 1/3 MCA territory) on CT or MRI;
  13. Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma);
  14. Pregnant women, nursing mothers, or reluctant to agree taking effective contraceptive measures during the period of trial subjects;
  15. 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;
  16. Participation in other interventional clinical trials within the previous 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: rhPro-UK (35mg)
rhPro-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).
Drug: Recombinant Human Prourokinase for Injection (rhPro-UK)
15mg of rhPro-UK intravenous bolus within 3 minutes, and the remaining 20mg intravenous drip within 30 minutes.
Other Names:
  • Puyouke
Active Comparator: standard medical treatment
Standard antiplatelet or anticoagulant treatment at the discretion of local investigators according to the 'Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018'.
Drug: standard medical treatment
Standard antiplatelet or anticoagulant treatment at the discretion of local investigators.
Other Names:
  • Aspirin, clopidogrel, anticoagulant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The modified Rankin Scale score (mRS) ≤ 1 at 90 days
Time Frame: 90 days
The proportion of the modified Rankin Scale score (mRS) ≤ 1 at 90 days.
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ordinal distribution of mRS at 90 days
Time Frame: 90 days
Ordinal distribution of mRS at 90 days
90 days
mRS score ≤ 2 at 90 days
Time Frame: 90 days
The proportion of mRS score ≤ 2 at 90 days
90 days
Early neurological functional improvement
Time Frame: 24 hours
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
24 hours
Barthel index of 75-100 points at 90 days
Time Frame: 90 days
The proportion of Barthel index of 75-100 points at 90 days
90 days
Quality of Life (EQ-5D-5L) at 90 days
Time Frame: 90 days
The value of Quality of Life (EQ-5D-5L) at 90 days
90 days
Activities of Daily Living (Lawton IADL) at 90 days
Time Frame: 90 days
The score of Activities of Daily Living (Lawton IADL) at 90 days
90 days
Symptomatic intracranial hemorrhage within 36 hours
Time Frame: 36 hours
The rate of symptomatic intracranial hemorrhage within 36 hours (as defined by ECASS III)
36 hours
All-cause death at 90 days
Time Frame: 90 days
All-cause mortality at 90 days
90 days
Systematic bleeding at 90 days
Time Frame: 90 days
The rate of systematic bleeding at 90 days (as defined by GUSTO: moderate and severe bleeding)
90 days
Adverse events (AEs)/ serious adverse events (SAEs) within 90 days
Time Frame: 90 days
The proportion of AEs/SAEs within 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yongjun Wang, MD, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HX-A-2022032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings