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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194968
• Other study ID #: UK-S001
• Status: Recruiting
• Start date: December 30, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: December 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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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.

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Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Urokinase
administered intravenously
• Alteplase
administered intravenously

Locations

Country	Name	City	State
China	The People's Hospital of Anyang City	Anyang	Henan
China	Beiliu People's Hospital	Beiliu	Guangxi
China	Guidong People's Hospital of Guangxi zhuang Autonomous Region	Guidong	Guangxi
China	The First Affiliated Hospital of Jiamusi University	Jiamusi	Heilongjiang
China	Kaifeng Central Hospital	Kaifeng	Henan
China	The First People's Hospital of Lanzhou City	Lanzhou	Gansu
China	The Second People's Hospital of Mengjin District	Luoyang	Henan
China	Pingdingshan The Second People's Hospital	Pingdingshan	Henan
China	Sanya People's Hospital	Sanya	Hainan
China	Affiliated Hospital of Inner Mongolia Minzu University	Tongliao	Inner Mongolia
China	Tengxian People's Hospital	Wuzhou	Guangxi
China	Red Cross Hospital of Yulin City	Yulin	Guangxi
China	The First People's Hospital of Yulin	Yulin	Guangxi
China	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	Huiji District People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University	Techpool Bio-Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin scale (mRS) 0-2 (good functional outcome) at day 90		at day 90