Evidence map›Paper›PMID 35505174›Full record

Trial reportTranslational stroke research2022

Efficacy and Safety of Recombinant Human Prourokinase in Acute Ischemic Stroke: A Phase IIa Randomized Clinical Trial.

Haiqing Song, Yuan Wang, Qingfeng Ma, Huisheng Chen, Bo Liu, Yi Yang, Jianguo Zhu, Shigang Zhao, Xiaoping Jin, Yongqiu Li and 17 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Translational stroke research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 6 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 6 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Efficacy and Safety of Recombinant Human Prourokinase in Acute Ischemic Stroke: A Systematic Review and Meta-Analysis.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  5. Head-to-Head: Recombinant Human Prourokinase Versus Intravenous Thrombolytics in Acute Ischemic Stroke Within 4.5 Hours - A Systematic Review and Network Meta-Analysis of Randomized Clinical Trials.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Advances in Reperfusion Therapy and Cytoprotection for Acute Ischemic Stroke.Journal of cardiovascular development and disease · 2026
    Review
  12. Rapid Blood Clot Removal via Remote Delamination and Magnetization of Clot Debris.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
    Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors at 18 institutions in 2 countries.

Haiqing SongDepartment of Neurology, Xuanwu Hospital, Capital Medicine University, 45 Chang Chun St, Beijing, 100053, China.
Yuan WangDepartment of Neurology, Xuanwu Hospital, Capital Medicine University, 45 Chang Chun St, Beijing, 100053, China.
Qingfeng MaDepartment of Neurology, Xuanwu Hospital, Capital Medicine University, 45 Chang Chun St, Beijing, 100053, China.
Huisheng ChenDepartment of Neurology, The General Hospital of Shenyang Military, Shenyang, Liaoning, China.
Bo LiuDepartment of Neurology, The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, Inner Mongolia, China.
Yi YangDepartment of Neurology, The First Hospital of Jilin University, Changchun, Jilin, China.
Jianguo ZhuDepartment of Neurology, Halison International Peace Hospital, Hengshui, Hebei, China.
Shigang ZhaoDepartment of Neurology, The Affiliated Hospital of Inner Mogolia Medical University, Huhhot, Inner Mogolia, China.
Xiaoping JinDepartment of Neurology, TaiZhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China.
Yongqiu LiDepartment of Neurology, Tangshan Worker's Hospital, Tangshan, Hebei, China.
Yanyong WangDepartment of Neurology, The First Hospital of Hebei University, Shijiazhuang, Hebei, China.
Runxiu ZhuDepartment of Neurology, Inner Mongolia People's Hospital, Huhhot, Inner Mogolia, China.
Liandong ZhaoDepartment of Neurology, The Second People's Hospital of Huai'an, Huai'an, Jiangsu, China.
Junyan LiuDepartment of Neurology, The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.
Qilin MaDepartment of Neurology, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, China.
Yongzhong LinDepartment of Neurology, The Second Hospital of Dalian Medical University, Dalian, Liaoning, China.
Xiangyang TianDepartment of Neurology, Huai'an First People's Hospital, Huai'an, Jiangsu, China.
Qing ZhangDepartment of Neurology, General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.
Weidong ZhouDepartment of Neurology, China Meitan General Hospital, Beijing, China.
Yongbo ZhangDepartment of Neurology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Jie ZhouDepartment of Neurology, Chongqing Sanxia Center Hospital, Chongqing, China.
Yansong LiDepartment of Neurology, Shenyang 463 Hospital, Shenyang, Liaoning, China.
Zhi SongDepartment of Neurology, The Third Xiangya Hospital of General South University, Changsha, Hunan, China.
Wuwei FengDepartment of Neurology, Duke University School of Medicine, Durham, NC, USA.
Rui LiuDepartment of Clinical Medicine, Tasly Biopharmaceuticals Co., Ltd, Tianjin, China.
Xunming JiDepartment of Neurosurgery, Xuanwu Hospital, Capital Medicine University, 45 Chang Chun St, Beijing, 100053, China. jixm@ccmu.edu.cn.
Yuping WangDepartment of Neurology, Xuanwu Hospital, Capital Medicine University, 45 Chang Chun St, Beijing, 100053, China. doctorwangyuping@163.com.ORCID http://orcid.org/0000-0002-6482-9710
Capital Medical University · CNTangshan People's Hospital · CNCentral South University · CNChongqing Emergency Medical Center · CNDalian Medical University · CNDuke University · USGeneral Hospital of Shenyang Military Region · CNHarrison International Peace Hospital · CNHebei Medical University · CNHuaian First People’s Hospital · CNInner Mongolia People's Hospital · CNInner Mongolia University of Science and Technology · CNJilin University · CNMeitan General Hospital · CNNingxia Medical University · CNTasly Holding Group (China) · CNWenzhou Medical University · CNXuzhou Medical College · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recombinant human prourokinase (rhPro-UK) is a novel thrombolytic that has been approved to treat patients with acute myocardial infarction. However, the safety and efficacy of intravenous rhPro-UK in patients with acute ischemic stroke (AIS) has not been well established. We aimed to investigate the safety and preliminary efficacy of rhPro-UK in patients with AIS in a multi-center phase IIa trial setting. One hundred nineteen patients within 4.5 h of AIS onset were enrolled in this randomized, open-label, 23-center phase IIa clinical trial. Patients were randomly assigned to 35 mg (n = 40) or 50 mg (n = 39) intravenous rhPro-UK or 0.9 mg/kg recombinant tissue plasminogen activator (r-tPA; n = 40). The primary endpoint was functional independence defined as a modified Rankin scale (mRS) score of 0 or 1 at 90 days. The secondary outcome was early neurological improvement defined as a reduction of ≥ 4 points on the National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 h after drug administration. Safety endpoints included death due to any cause, symptomatic intracerebral hemorrhage (sICH), and other serious adverse events (SAEs). The proportion of patients with an mRS score of ≤ 1 at 90 days did not differ significantly among three groups (35 mg rhPro-UK: 55.56% vs. 50 mg rhPro-UK: 57.89% vs. vs. r-tPA: 52.63%; P = 0.92). The rates of treatment response, referring to early neurological improvement, were similar among these three groups (36.11% vs. 31.58% vs. 28.95%, respectively; P = 0.85). There was no difference in mortality at 90 days or in the rate of other SAEs among the three groups. One patient in the 50 mg rhPro-UK group suffered sICH. While neither the primary efficacy outcomes nor safety profile differed significantly among the low, high rhPro-UK and control groups, it is a logical step to further test the low-dose rhPro-UK group versus the control group in a well-powered phase III study.Trial Registration: http://www.chictr.org.cn . Identifier: ChiCTR1800016519. Date of registration: June 6 2018.

Indexed as

Brain IschemiaIschemic StrokeStrokeCerebral HemorrhageFibrinolytic AgentsHumansThrombolytic TherapyTissue Plasminogen ActivatorTreatment OutcomeFibrinolytic AgentsTissue Plasminogen ActivatorAcute ischemic strokeEarly neurological improvementEfficacyRecombinant human prourokinaseSafetyThrombolytic therapy

Identifiers

PMID35505174
OpenAlexW4225309632

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.