New stroke drug could boost recovery when given hours after symptoms
NCT ID NCT07389460
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times
Summary
This phase 3 trial tests whether giving a clot-busting drug called rhPro-UK before a mechanical clot removal procedure improves recovery for people with severe stroke. About 820 participants who had a stroke 4.5 to 24 hours earlier will receive either the drug or a placebo, followed by the standard clot removal. The main goal is to see if more people can live independently 90 days later.
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 it works, this could offer a new treatment to improve recovery for stroke patients who can't get clot-busting drugs right away.
- What could go wrong
- This is still being tested, so it may not work better than placebo. There is also a risk of bleeding in the brain, which could be serious.
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 820 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 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. Acute ischemic stroke presenting within 4.5-24 hours of last known well; 3. No significant pre-stroke functional disability: for age \<80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1; 4. Baseline NIHSS score ≥6; 5. Imaging criteria of BOTH: 1\. Occlusion on CTA/MRA in one of the following vessels: M1/M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, V4 segment of vertebral artery, basilar artery, or P1 segment of posterior cerebral artery. For A1, or P1 occlusions, vessel diameter must be ≥0.75 mm; 2. For anterior circulation occlusion: CTP/MRP demonstrating mismatch ratio ≥1.8, absolute mismatch volume ≥15 mL, and ischemic core volume \<70 mL; OR have a mismatch between the presence of an abnormal signal on MRI diffusion-weighted imaging and no visible signal change on FLAIR. For posterior circulation occlusion: pc-ASPECTS score ≥6. 6\. Plan to received endovascular thrombectomy; 7. The patient or their legal representative provides written informed consent. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by CT/MRI; 2. Onset accompanied by epileptic seizures, resulting in questionable stroke diagnosis and inability to obtain an accurate baseline NIHSS score; 3. Women who are pregnant or breastfeeding, or have a positive serum β-HCG test upon admission; 4. Already received intravenous thrombolytic after index stroke; 5. History of prior intracranial hemorrhage, including cerebral parenchymal hemorrhage, subarachnoid hemorrhage, and subdural/extradural hematoma; 6. Active bleeding or bleeding tendency, such as gastrointestinal bleeding, urinary tract bleeding, retinal hemorrhage, etc., or presence of coagulation dysfunction; 7. History of major recent surgery or trauma, such as intracranial or spinal surgery within the past 3 months, major surgery within the past 2 weeks, or severe head trauma within the past 3 weeks; 8. Baseline blood glucose \<2.8 mmol/L or \>22.2 mmol/L; 9. Received low molecular weight heparin within 24 hours, or oral anticoagulants with an International Normalized Ratio (INR) \>1.7, or thrombin inhibitors within 48 hours, among others; 10. Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel; 11. Pre-existing neurological/psychiatric disorders interfering with neurological assessment; 12. Space-occupying intracranial tumors (except for small meningiomas); 13. Intracranial aneurysm or arteriovenous malformation; 14. Terminal illness with life expectancy \<6 months; 15. Concurrent participation in other investigation clinical trials; 16. Presence of other conditions deemed by the investigator as unsuitable for participation in the study.
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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
10 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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First Affiliated Hospital of Xi'an Jiaotong University
RECRUITINGXi'an, Shaanxi, China
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Henan Provincial People's Hospital
RECRUITINGZhengzhou, Henan, China
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Loudi Central Hospital
RECRUITINGLoudi, Hunan, China
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Qinghai Provincial People's Hospital
RECRUITINGXining, Qinghai, China
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Shanxi Cardiovascular Hospital
RECRUITINGTaiyuan, Shanxi, China
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The First Affiliated Hospital of Shihezi University
RECRUITINGShihezi, Xinjiang Uygur Autonomous Region, China
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The First Hospital of Lanzhou University
RECRUITINGLanzhou, Gansu, China
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The Second Hospital of Dalian Medical University
RECRUITINGDalian, Liaoning, China
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The Third Hospital of Hebei Medical University
RECRUITINGShijiazhuang, Hebei, China
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Xuanwu Hospital Capital Medical University
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better