Could a higher dose of urokinase save more brains after stroke?
NCT ID NCT07047326
First seen Jun 24, 2026 · Last updated Jul 15, 2026 · Updated 3 times
Summary
This study tests increasing doses of the clot-busting drug urokinase in 24 people with acute ischemic stroke, given within 6 hours of symptoms. The goal is to find the highest safe dose and develop a weight-based dosing plan. Researchers will watch closely for bleeding complications to balance safety and effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- urokinase
- What this could lead to
- If successful, this could establish a safer, more effective weight-based dosing regimen for urokinase, potentially improving stroke outcomes at a lower cost than current alternatives.
- What could go wrong
- This is a very early, small safety study with only 24 participants. The main risk is bleeding in the brain, and higher doses may not prove safer or more effective than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-80 years, male or female. 2. Clinical diagnosis as ischemic stroke (the diagnosis following the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023). 3. 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. 4. NIHSS ≥1 at baseline. 5. Subjects or their guardians voluntarily sign the informed consent. Exclusion Criteria: 1. Head CT or MRI shows a large infarction (infarcted area \>1/3 of the middle cerebral artery). 2. Unknown time of stroke onset. 3. Pre-stroke mRS score ≥2. 4. NIHSS score 1A ≥2. 5. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.). 6. A history of intracranial hemorrhage. 7. Propensity for acute bleeding, including platelet count \<100 × 10⁹/L or otherwise. 8. Having received heparin treatment within 24 h. 9. On oral anticoagulants (e.g., warfarin) with INR \>1.7 or PT \>15s. 10. Patients with planned or prior endovascular therapy. 11. A history of severe head trauma or stroke within 3 months. 12. Intracranial tumors, large intracranial aneurysms. 13. A history of intracranial or spinal surgery within 3 months. 14. A history of major surgery within 2 weeks. 15. Severe liver impairment (e.g., liver failure, cirrhosis, portal hypertension \[esophageal varices\], active hepatitis). 16. A history of gastrointestinal or urinary tract hemorrhage within 3 weeks. 17. Active visceral bleeding. 18. Aortic dissection found. 19. A history of arterial puncture at sites difficult for compression hemostasis within 1 week. 20. Life expectancy \<1 year due to comorbid conditions. 21. 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. 22. Blood glucose \<2.8 mmol/L or \>22.2 mmol/L. 23. Subjects who are unable or unwilling to cooperate due to hemiplegia after epileptic seizure or other neurological/psychiatric disorders. 24. Known to be allergic to urokinase. 25. Bacterial endocarditis, pericarditis, or acute pancreatitis. 26. Participation in other clinical trials within 30 days before screening. 27. Pregnancy, lactating women, or subjects who do not agree to use effective contraception during the trial. 28. Other conditions deemed by the investigator to impair adherence or pose risks to participants.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Handan Central Hospital
RECRUITINGHandan, Hebei, 056002, China
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Xuanwu Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100053, China
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Other studies related to the condition(s) this trial covers.
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- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
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- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better