Can a swift Clot-Buster boost stroke recovery?
NCT ID NCT07787325
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This study looks at whether a clot-busting drug called prourokinase can improve recovery in people who have an acute ischemic stroke, when given within 4.5 hours of symptoms starting. About 3,000 adults will receive the drug intravenously and be followed for 90 days to see how well they recover and whether any bleeding or other side effects occur. The goal is to gather real-world evidence on how well this treatment works in everyday practice.
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 (a clot-busting drug given intravenously)
- What this could lead to
- If successful, this could strengthen evidence for prourokinase as a standard treatment to improve recovery after stroke.
- What could go wrong
- This is an observational registry, not a randomized trial, so results may be influenced by patient selection. Bleeding risk is a known concern with clot-busting drugs.
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.
- Participants
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About 3,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
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.
Who is studied
Adults with acute ischemic stroke who receive intravenous recombinant human prourokinase treatment within 4.5 hours of symptom onset. Eligible participants are patients aged ≥18 years with a pre-stroke modified Rankin Scale (mRS) score of 0-1 who are considered suitable for intravenous thrombolysis with recombinant human prourokinase by the treating investigator.
- 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: * Adults aged ≥18 years, regardless of sex. * Pre-stroke modified Rankin Scale (mRS) score of 0-1. * Patients with acute ischemic stroke treated within 4.5 hours of symptom onset, who are considered suitable for intravenous thrombolysis with recombinant human prourokinase by the treating investigator. * Written informed consent obtained from the participant or legally authorized representative. Exclusion Criteria: * Known severe hypersensitivity to recombinant human prourokinase. * Other severe neurological, psychiatric, or systemic diseases that may interfere with outcome assessment, adherence, or follow-up. * Uncontrolled severe hypertension before treatment (systolic blood pressure ≥185 mmHg or diastolic blood pressure ≥110 mmHg despite antihypertensive therapy). * Blood glucose \<2.8 mmol/L or \>22.2 mmol/L that remains uncontrolled after correction. * Active internal bleeding or high bleeding risk, including gastrointestinal or urinary tract bleeding within 21 days, major surgery, severe trauma, major organ biopsy within 21 days, non-compressible arterial puncture within 7 days, or other significant bleeding risks. * Known coagulation abnormalities or bleeding tendency, including platelet count \<100 × 10⁹/L, INR \>1.7, clinically significant PT prolongation, clinically significant APTT prolongation, or markedly decreased fibrinogen levels. * Current or recent anticoagulant use associated with increased bleeding risk, including vitamin K antagonists with INR \>1.7, direct thrombin inhibitors or factor Xa inhibitors within 48 hours with abnormal coagulation tests, or heparin within 24 hours with elevated APTT. * History of ischemic stroke, severe head trauma, or myocardial infarction within 3 months. * History of intracranial hemorrhage. * Intracranial or spinal surgery within 3 months. * Known intracranial neoplasm, arteriovenous malformation, large intracranial aneurysm, or other intracranial lesions associated with increased risk of intracranial hemorrhage. * Baseline CT showing intracranial hemorrhage, including intracerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma. * Extensive infarction or significant early ischemic changes on baseline imaging considered unsuitable for intravenous thrombolysis. * Severe hepatic dysfunction, severe renal dysfunction, severe infection, active malignancy, terminal illness, or other serious conditions with expected survival \<3 months. * Pregnancy, breastfeeding, or positive pregnancy test in women of childbearing potential. * Unable to complete 90-day follow-up, poor compliance, or other conditions considered unsuitable for study participation by the investigator.
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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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The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better
- Can a stroke drug shrink brain damage after clot removal?
- Can a new drug boost recovery after stroke surgery?
- AI could forecast stroke outcomes in real time
- Can a Late-Acting clot buster improve stroke recovery?