Status:
RECRUITING
Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsors:
Techpool Bio-Pharma Co., Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
December 30 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT06194968
Start Date
December 30 2023
End Date
December 1 2026
Last Update
January 8 2024
Active Locations (16)
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1
The First People's Hospital of Lanzhou City
Lanzhou, Gansu, China, 730000
2
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China, 524000
3
Beiliu People's Hospital
Beiliu, Guangxi, China, 537400
4
Guidong People's Hospital of Guangxi zhuang Autonomous Region
Guidong, Guangxi, China, 546612