Treatment of Acute Ischemic StroKe With Intravenous UroKinase Real-world Research: a Multicenter, Prospective Study
1 other identifier
observational
1,800
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2023
CompletedStudy Start
First participant enrolled
December 30, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJanuary 8, 2024
December 1, 2023
1.8 years
November 10, 2023
December 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
modified Rankin scale (mRS) 0-2 (good functional outcome) at day 90
at day 90
Study Arms (2)
Experimental: Urokinase
Active Comparator: Alteplase
Interventions
Eligibility Criteria
Patients with acute ischemic stroke who meet all inclusion criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
The First People's Hospital of Lanzhou City
Lanzhou, Gansu, 730000, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000, China
Beiliu People's Hospital
Beiliu, Guangxi, 537400, China
Guidong People's Hospital of Guangxi zhuang Autonomous Region
Guidong, Guangxi, 546612, China
Tengxian People's Hospital
Wuzhou, Guangxi, 543300, China
Red Cross Hospital of Yulin City
Yulin, Guangxi, 537000, China
The First People's Hospital of Yulin
Yulin, Guangxi, 537099, China
Sanya People's Hospital
Sanya, Hainan, 57200, China
The First Affiliated Hospital of Jiamusi University
Jiamusi, Heilongjiang, 154002, China
The People's Hospital of Anyang City
Anyang, Henan, 455000, China
Kaifeng Central Hospital
Kaifeng, Henan, 475000, China
The Second People's Hospital of Mengjin District
Luoyang, Henan, 471100, China
Pingdingshan The Second People's Hospital
Pingdingshan, Henan, 467000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 0371, China
Huiji District People's Hospital
Zhengzhou, Henan, 450053, China
Affiliated Hospital of Inner Mongolia Minzu University
Tongliao, Inner Mongolia, 028000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief physician
Study Record Dates
First Submitted
November 10, 2023
First Posted
January 8, 2024
Study Start
December 30, 2023
Primary Completion
November 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
January 8, 2024
Record last verified: 2023-12