Urokinase for Thrombolysis in Acute Ischemic Stroke
ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCapital Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-80 years, male or female.
Clinical diagnosis as ischemic stroke (the diagnosis following the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023).
Time from onset to treatment <6h; the time of symptom onset is defined as "the last time point at which the patient appears normal", and the symptoms of stroke persist for at least 30 minutes and show no significant improvement before treatment.
NIHSS ≥1 at baseline.
Disqualifiers
Head CT or MRI shows a large infarction (infarcted area >1/3 of the middle cerebral artery).
Unknown time of stroke onset.
Pre-stroke mRS score ≥2.
NIHSS score 1A ≥2.
Trial design
Design model
Single group
Treatments tested in this trial
Urokinase thrombolysis
DrugThe intravenous thrombolysis group was administered urokinase dissolved in 100 mL of saline via continuous intravenous infusion for 30 min, and the treatment was given within 6 h of stroke onset. The dose escalation plan includes the following increments: 15,000 IU/kg (maximum dose: 1.5 million IU), 20,000 IU/kg (maximum dose: 2.0 million IU), 25,000 IU/kg (maximum dose: 2.5 million IU), and 30,000 IU/kg (maximum dose: 3.0 million IU).
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Intravenous urokinase groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with major response
Major response is any of the following: 1. Symptomatic intracranial hemorrhage; 2. Parenchymal hemorrhage type 2; 3. Any intracranial hemorrhage; 4. Major bleeding and clinically relevant non-major bleeding.
Time frame
Within 36 hours after intravenous thrombolysisSponsors and contacts
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Source ClinicalTrials.gov