Actively Recruiting
Urokinase for Thrombolysis in Acute Ischemic Stroke
Led by Capital Medical University · Updated on 2025-11-26
24
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
According to the Chinese Guidelines for the Diagnosis and Treatment of Ischemic Stroke, intravenous thrombolysis with urokinase, administered at doses of 1-1.5 million IU within 6 hours of symptom onset, has been shown to be both safe and effective for patients with acute ischemic stroke. Compared to alteplase, urokinase offers considerable cost advantages while maintaining comparable therapeutic efficacy. However, current dosing protocols in clinical practice largely rely on the empirical judgment of physicians rather than evidence-based standardization. Therefore, the development of a weight-adjusted dosing regimen for urokinase is of significant clinical importance in optimizing treatment outcomes and ensuring patient safety. The purpose of this study is to determine the maximum tolerated dose of urokinase thrombolytic treatment in patients with acute ischemic stroke and to develop an optimal weight-adjusted dosing regimen.
CONDITIONS
Official Title
Urokinase for Thrombolysis in Acute Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years, male or female
- Clinical diagnosis of ischemic stroke according to Chinese Guidelines for Acute Ischemic Stroke 2023
- Time from symptom onset to treatment less than 6 hours
- Stroke symptoms lasting at least 30 minutes without significant improvement before treatment
- National Institutes of Health Stroke Scale (NIHSS) score of 1 or higher at baseline
- Voluntary informed consent signed by the subject or their guardian
You will not qualify if you...
- Large infarction involving more than one-third of the middle cerebral artery seen on CT or MRI
- Unknown time of stroke onset
- Pre-stroke modified Rankin Scale (mRS) score of 2 or higher
- NIHSS score 1A of 2 or higher
- Presence of any intracranial hemorrhage
- History of intracranial hemorrhage
- Bleeding tendency including platelet count below 100 x 10^9/L
- Heparin treatment within 24 hours prior to study
- Use of oral anticoagulants with INR greater than 1.7 or PT greater than 15 seconds
- Planned or prior endovascular therapy
- History of severe head trauma or stroke within 3 months
- Intracranial tumors or large intracranial aneurysms
- Intracranial or spinal surgery within 3 months
- Major surgery within 2 weeks
- Severe liver impairment including liver failure, cirrhosis, portal hypertension, or active hepatitis
- Gastrointestinal or urinary tract bleeding within 3 weeks
- Active visceral bleeding
- Aortic dissection
- Arterial puncture at sites difficult to compress within 1 week
- Life expectancy less than 1 year due to other conditions
- Uncontrolled high blood pressure despite treatment
- Blood glucose less than 2.8 mmol/L or greater than 22.2 mmol/L
- Inability or unwillingness to cooperate due to neurological or psychiatric disorders
- Known allergy to urokinase
- Bacterial endocarditis, pericarditis, or acute pancreatitis
- Participation in another clinical trial within 30 days before screening
- Pregnancy, breastfeeding, or refusal to use contraception during the trial
- Other conditions judged by investigators to impair participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Research Team
J
Ji Xunming
CONTACT
Z
Zhao Wenbo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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