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Acute Ischemic StrokeNCT06194968

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

An observational study of Acute Ischemic Stroke, run by The First Affiliated Hospital of Zhengzhou University at 16 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Urokinase and Alteplase
Type of treatment
Injection or infusion
How many people
1,800 participants
Where
16 sitesChina
Study dates
30 Dec 2023to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Patients with acute ischemic stroke who meet all inclusion criteria

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.

-

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

16 sites in 1 country

China16 sites, 16 recruiting

  • The People's Hospital of Anyang City

    Anyang, Henan, 455000

    Not yet recruiting

  • Beiliu People's Hospital

    Beiliu, Guangxi, 537400

    Not yet recruiting

  • Guidong People's Hospital of Guangxi zhuang Autonomous Region

    Guidong, Guangxi, 546612

    Not yet recruiting

  • The First Affiliated Hospital of Jiamusi University

    Jiamusi, Heilongjiang, 154002

    Not yet recruiting

  • Kaifeng Central Hospital

    Kaifeng, Henan, 475000

    Not yet recruiting

  • The First People's Hospital of Lanzhou City

    Lanzhou, Gansu, 730000

    Not yet recruiting

  • The Second People's Hospital of Mengjin District

    Luoyang, Henan, 471100

    Not yet recruiting

  • Pingdingshan The Second People's Hospital

    Pingdingshan, Henan, 467000

    Not yet recruiting

  • Sanya People's Hospital

    Sanya, Hainan, 57200

    Not yet recruiting

  • Affiliated Hospital of Inner Mongolia Minzu University

    Tongliao, Inner Mongolia, 028000

    Not yet recruiting

  • Tengxian People's Hospital

    Wuzhou, Guangxi, 543300

    Not yet recruiting

  • Red Cross Hospital of Yulin City

    Yulin, Guangxi, 537000

    Not yet recruiting

  • The First People's Hospital of Yulin

    Yulin, Guangxi, 537099

    Not yet recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524000

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 0371

    Yongli Tao, MD, +86-371-66278068, tyl2112@126.com

    Yafang Xu, MD;PHD, +86-371-66278067, yafangxu321@163.com

    Recruiting

  • Huiji District People's Hospital

    Zhengzhou, Henan, 450053

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Urokinase, Alteplase
Medical subject headings
Ischemic Stroke

What participants receive

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

  • UrokinaseDrug

    administered intravenously

  • AlteplaseDrug

    administered intravenously

Study groups in NCT06194968
Study groupRoleWhat they receive
Experimental: UrokinaseNot described
Receives: Drug: Urokinase
Active Comparator: AlteplaseNot described
Receives: Drug: Alteplase

What is being measured

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

  1. modified Rankin scale (mRS) 0-2 (good functional outcome) at day 90

    Measured: at day 90

Timeline

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

  1. First posted8 Jan 2024
  2. Study start30 Dec 2023 (estimated)
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06194968
Sponsor's protocol ID
UK-S001
Status last verified
Dec 2023
First submitted
10 Nov 2023
Last updated
8 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tao Y, Fang H, Pei L, Gao Y, Liu K, Wang X, Zhang R, Cao Z, Zhou Y, Zhang D, Qian Y, Pan Y, Xu Y, Song B. Treatment of Acute Ischemic Stroke with Intravenous Urokinase (TASK-UK): Protocol for a Multicenter, Prospective, Real-World Study. Neurol Ther. 2026 Aug 8. doi: 10.1007/s40120-026-01006-x. Online ahead of print.

    PubMed 42570202

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Ischemic Stroke, run by The First Affiliated Hospital of Zhengzhou University at 16 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?

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: looking for participants now, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin scale (mRS) 0-2 (good functional outcome) at day 90 (time frame: at day 90). 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 NCT06194968, which also lists 1 linked publication.

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 8 Jan 2024.

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