New hope for stroke patients: drug may restore brain function hours later
NCT ID NCT07617870
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a drug called pro-urokinase in people who have had a stroke in the back part of the brain (posterior circulation) and can be treated within 4.5 to 24 hours after symptoms start. About 586 participants will receive either the drug or a placebo, along with standard aspirin therapy. The goal is to see if the drug helps more people achieve a good recovery (minimal or no disability) at 90 days, compared to standard care alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- recombinant human prourokinase (rhPro-UK)
- What this could lead to
- If successful, this could provide a new treatment option for certain stroke patients who are not eligible for clot removal, potentially improving recovery and reducing disability.
- What could go wrong
- This is an early-stage Phase 3 trial with 586 participants, so results may not apply to all stroke patients. The drug also carries bleeding risks, which could limit its safety and effectiveness.
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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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 586 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
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 years and older
- 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 years; 2. AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed); 3. Imaging criteria: 1. DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR; 2. DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory; 4. NIHSS score 4-25; 5. First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1); 6. Signed informed consent from the patient or legally authorized representative. Exclusion Criteria: 1. Planned endovascular treatment; 2. Contradictory to MRI examination; 3. MRI image not qualified for evaluation; 4. Serious neurological deficits before onset (mRS≥2); 5. Obvious head injuries or strokes within 3 months; 6. Subarachnoid or intracranial hemorrhage; 7. History of intracranial hemorrhage; 8. Intracranial tumor, arteriovenous malformation or aneurysm; 9. Intracranial or spinal cord surgery within 3 months; 10. Active internal hemorrhage; 11. platelet count of \<100000/mm3; 12. Aortic arch dissection; 13. Heparin therapy within 24 hours; 14. Oral warfarin is being taken and INR\>1.6 or APTT abnormal; 15. Oral anticoagulation therapy; 16. Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg; 17. Blood glucose \< 50 mg/dl (2.7mmol/L); 18. Pregnancy; 19. Neurological deficit after epileptic seizures; 20. Major surgery within 1 month; 21. Gastrointestinal or urinary tract hemorrhage within the previous 30 days; 22. Myocardial infarction within 3 months; 23. Allergy to study drugs; 24. Unlikely to adhere to the trial protocol or follow-up; 25. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study; 26. Participation in other interventional clinical trials within the previous 3 months.
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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
1 site. 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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Department of Neurology, the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a kidney protein drug boost stroke recovery after clot removal?
- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Cancer patients face a hidden Second-Stroke threat, and 24 hospitals are mapping it
- Can tiny neural exosomes help the brain heal after a severe stroke?