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Could a higher dose of urokinase save more brains after stroke?

NCT ID NCT07047326

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Handan Central Hospital

    RECRUITING

    Handan, Hebei, 056002, China

  • Xuanwu Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

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