Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study

December 22, 2023 updated by: Bo Song, The First Affiliated Hospital of Zhengzhou University

Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study (TASK-UK)

The purpose of this study is to to compare the safety and effectiveness of IV urokinase with IV alteplase in the treatment of AIS in patients up to 6 hours from symptom onset.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Recombinant tissue plasminogen activator (alteplase) is currently the recommended treatment of AIS in patients within 0 to 4.5 hours from symptom onset. The cost of a single treatment with this drug is around 5000 RMB (about 700 USD). In contrast, the cost of a single dose of urokinase is around 300 RMB (about 40 USD), making it much more affordable. Currently, existing evidence regarding the effectiveness and safety of urokinase is mixed. Some studies propose that urokinase thrombolysis, compared with alteplase thrombolysis, improves perfusion without increasing the incidence of adverse reactions and mortality. In some cases, using urokinase for thrombolysis even lowers the risk of systemic bleeding, comparing to alteplase. Other studies suggest that the effectiveness and safety of urokinase intreating AIS patients is infeiror comparing to alteplase . In this study, we plan to conduct a nationwide multicenter real-world study on urokinase intravenous thrombolysis with alteplase as an active control. We will observe and analyze AIS patients treated with urokinase and alteplase and compare the effectiveness, safety and economic effects. We will explore different urokinase dosage efficacy indicators and analyze relevant risk factors. This will provide data for future systematic evaluations of the clinical effects of urokinase thrombolysis which may help lower the medical costs in treating AIS while ensuring the effectiveness.

Study Type

Observational

Enrollment (Estimated)

1800

Contacts and Locations

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

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • The First People's Hospital of Lanzhou City
    • Guangdong
      • Zhanjiang, Guangdong, China, 524000
        • Not yet recruiting
        • Affiliated Hospital of Guangdong Medical University
    • Guangxi
      • Beiliu, Guangxi, China, 537400
        • Not yet recruiting
        • Beiliu People's Hospital
      • Guidong, Guangxi, China, 546612
        • Not yet recruiting
        • Guidong People's Hospital of Guangxi Zhuang Autonomous Region
      • Wuzhou, Guangxi, China, 543300
        • Not yet recruiting
        • Tengxian People's Hospital
      • Yulin, Guangxi, China, 537000
        • Not yet recruiting
        • Red Cross Hospital of Yulin City
      • Yulin, Guangxi, China, 537099
        • Not yet recruiting
        • The First People's Hospital of Yulin
    • Hainan
      • Sanya, Hainan, China, 57200
        • Not yet recruiting
        • Sanya People's Hospital
    • Heilongjiang
      • Jiamusi, Heilongjiang, China, 154002
        • Not yet recruiting
        • The First Affiliated Hospital of Jiamusi University
    • Henan
      • Anyang, Henan, China, 455000
        • Not yet recruiting
        • The People's Hospital of Anyang City
      • Kaifeng, Henan, China, 475000
        • Not yet recruiting
        • Kaifeng Central Hospital
      • Luoyang, Henan, China, 471100
        • Not yet recruiting
        • The Second People's Hospital of Mengjin District
      • Pingdingshan, Henan, China, 467000
        • Not yet recruiting
        • Pingdingshan The second people's hospital
      • Zhengzhou, Henan, China, 0371
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Contact:
      • Zhengzhou, Henan, China, 450053
        • Not yet recruiting
        • Huiji District People's Hospital
    • Inner Mongolia
      • Tongliao, Inner Mongolia, China, 028000
        • Not yet recruiting
        • Affiliated Hospital of Inner Mongolia Minzu University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute ischemic stroke who meet all inclusion criteria

Description

Inclusion Criteria:Age: ≥18 years. Clinical diagnosis of acute ischemic stroke, defined as an event characterized by the sudden onset of an acute focal neurologic deficit, unilateral motor dysfunction or impairment of language presumed to be due to cerebral ischemia after, with imaging evidence of a causative lesion or symptoms/signs persisting for over 24 hours. CT scan should exclude hemorrhage and non-vascular etiology.

First-time occurrence or a history of stroke without significant neurological deficits (baseline mRS score ≤ 1).

Eligible for treatment with intravenous administration of urokinase or alteplase as assessed by the investigators.

Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable.

-

Exclusion Criteria:Contraindications for thrombolysis (refer to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke, intravenous thrombolysis contraindications).

Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.

Known history of drug (narcotics, controlled substances) abuse or addiction in the past year.

Has an expected survival of less than 90 days due to concurrent malignant tumors or severe systemic diseases Incapable to comply with the protocol due to mental illness or cognitive disorder.

Paticipants of any interventional drug or device clinical trials within 3 months prior to screening.

Unsuitable for this study in the opinion of the investigators.

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental: Urokinase
Drug: Urokinase
administered intravenously
Active Comparator: Alteplase
Drug: Alteplase
administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
modified Rankin scale (mRS) 0-2 (good functional outcome) at day 90
Time Frame: at day 90
at day 90

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Zhengzhou University

Collaborators

Techpool Bio-Pharma Co., Ltd.

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 (Estimated)

December 30, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

December 22, 2023

First Posted (Estimated)

January 8, 2024

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UK-S001

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.

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