Clinical trial NCT06194968: Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study
Official title: Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study (TASK-UK)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Techpool Bio-Pharma Co., Ltd.
First posted: 2024-01-08
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke who meet all inclusion criteria

Brief 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.

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.

Eligibility 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.

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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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Primary outcomes:
measure: modified Rankin scale (mRS) 0-2 (good functional outcome) at day 90
timeFrame: at day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The First People's Hospital of Lanzhou City
state: Gansu
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Beiliu
country: China
facility: Beiliu People's Hospital
state: Guangxi
city: Guidong
country: China
facility: Guidong People's Hospital of Guangxi zhuang Autonomous Region
state: Guangxi
city: Wuzhou
country: China
facility: Tengxian People's Hospital
state: Guangxi
city: Yulin
country: China
facility: Red Cross Hospital of Yulin City
state: Guangxi
city: Yulin
country: China
facility: The First People's Hospital of Yulin
state: Guangxi
city: Sanya
country: China
facility: Sanya People's Hospital
state: Hainan
city: Jiamusi
country: China
facility: The First Affiliated Hospital of Jiamusi University
state: Heilongjiang
city: Anyang
country: China
facility: The People's Hospital of Anyang City
state: Henan
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Luoyang
country: China
facility: The Second People's Hospital of Mengjin District
state: Henan
city: Pingdingshan
country: China
facility: Pingdingshan The Second People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Huiji District People's Hospital
state: Henan
city: Tongliao
country: China
facility: Affiliated Hospital of Inner Mongolia Minzu University
state: Inner Mongolia
Study officials:
References: