Testing Urokinase Doses for Clot-Busting Treatment in Acute Stroke
Tests different urokinase doses to find a safe amount for adults with ischemic stroke.
Plain-language title generated from the registry record
Registry title: Urokinase for Thrombolysis in Acute Ischemic Stroke
Key facts
- Where
- Beijing and Handan, ChinaSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 who had an ischemic stroke less than 6 hours ago and can be treated with urokinase to dissolve the clot.
- Age
- 18 to 80 years
- Sex
- Men and women can join.
- Disease stage
- Acute ischemic stroke, less than 6 hours from the start of symptoms. Symptoms last at least 30 minutes without clear improvement. NIHSS score of 1 or more at the start.
- Earlier treatment
- People with planned or earlier endovascular therapy cannot join. People who had heparin within 24 hours cannot join.
Main reasons for not taking part
- Large infarction on head CT or MRI, or any bleeding in the brain, now or in the past
- Unknown time of stroke onset
- Bleeding tendency, platelet count below 100 × 10⁹/L, or major surgery within 2 weeks
- Blood pressure of 180 mm Hg systolic or 100 mm Hg diastolic or higher that cannot be controlled
- Pregnancy or breastfeeding
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07047326, who can take part
Where in China
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- Handan Central HospitalHandan, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Capital Medical University
- Trial code
- NCT07047326
- Record updated
- 14 July 2026
- Original description
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.Read full original descriptionShow less
A Dose-Escalation Safety Study of Urokinase for Thrombolysis in Patients With Acute Ischemic Stroke
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.
Inclusion: 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; Subjects or their guardians voluntarily sign the informed consent.
Exclusion: Having received heparin treatment within 24 h; Patients with planned or prior endovascular therapy; Participation in other clinical trials within 30 days before screening; Unknown time of stroke onset; Pre-stroke mRS score ≥2; Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.); A history of intracranial hemorrhage; A history of severe head trauma or stroke within 3 months; A history of intracranial or spinal surgery within 3 months; A history of major surgery within 2 weeks; Severe liver impairment (e.g., liver failure, cirrhosis, portal hypertension [esophageal varices], active hepatitis); A history of gastrointestinal or urinary tract hemorrhage within 3 weeks; Active visceral bleeding; A history of arterial puncture at sites difficult for compression hemostasis within 1 week; Life expectancy <1 year due to comorbid conditions; Uncontrollable hypertension upon active antihypertensive treatment: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg on ≥3 repeated measurements at 10-minute intervals; Subjects who are unable or unwilling to cooperate due to hemiplegia after epileptic seizure or other neurological/psychiatric disorders; Known to be allergic to urokinase; Other conditions deemed by the investigator to impair adherence or pose risks to participants; Propensity for acute bleeding, including platelet count <100 × 10⁹/L or otherwise; On oral anticoagulants (e.g., warfarin) with INR >1.7 or PT >15s; Blood glucose <2.8 mmol/L or >22.2 mmol/L; Head CT or MRI shows a large infarction (infarcted area >1/3 of the middle cerebral artery); NIHSS score 1A ≥2; Intracranial tumors, large intracranial aneurysms; Aortic dissection found; Bacterial endocarditis, pericarditis, or acute pancreatitis; Pregnancy, lactating women, or subjects who do not agree to use effective contraception during the trial.