The First Affiliated Hospital of Zhengzhou University
Phase
Observational
Started
2023-12-30
Last updated
2024-01-08
Condition(s) studied
Acute Ischemic Stroke
Investigational drug(s) / intervention(s)
UrokinaseAlteplase
Urokinase: administered intravenously
Alteplase: administered intravenously
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
modified Rankin scale (mRS) 0-2 (good functional outcome) at day 90 — at day 90
Trial sites (16)
Facility
City
Region
Status
The First People's Hospital of Lanzhou City
Lanzhou
Gansu
Not Yet Recruiting
Affiliated Hospital of Guangdong Medical University
Zhanjiang
Guangdong
Not Yet Recruiting
Beiliu People's Hospital
Beiliu
Guangxi
Not Yet Recruiting
Guidong People's Hospital of Guangxi zhuang Autonomous Region
Guidong
Guangxi
Not Yet Recruiting
Tengxian People's Hospital
Wuzhou
Guangxi
Not Yet Recruiting
Red Cross Hospital of Yulin City
Yulin
Guangxi
Not Yet Recruiting
The First People's Hospital of Yulin
Yulin
Guangxi
Not Yet Recruiting
Sanya People's Hospital
Sanya
Hainan
Not Yet Recruiting
The First Affiliated Hospital of Jiamusi University
Jiamusi
Heilongjiang
Not Yet Recruiting
The People's Hospital of Anyang City
Anyang
Henan
Not Yet Recruiting
Kaifeng Central Hospital
Kaifeng
Henan
Not Yet Recruiting
The Second People's Hospital of Mengjin District
Luoyang
Henan
Not Yet Recruiting
Pingdingshan The Second People's Hospital
Pingdingshan
Henan
Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Recruiting
Huiji District People's Hospital
Zhengzhou
Henan
Not Yet Recruiting
Affiliated Hospital of Inner Mongolia Minzu University
Tongliao
Inner Mongolia
Not Yet Recruiting
More The First Affiliated Hospital of Zhengzhou University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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