New drug cocktail aims to boost stroke recovery
NCT ID NCT07483281
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a drug called human urinary kallidinogenase to standard clot-busting therapy can improve recovery after a stroke. About 220 adults who have had a moderate stroke will be randomly assigned to receive the combination or standard care alone. The main goal is to see if more people achieve a good functional outcome (no or minimal disability) after 90 days.
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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 220 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 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. Meet the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023 2. Age ≥ 18 years 3. The time from last known well to treatment is within 4.5 hours 4. First-ever ischemic stroke or have history of ischemic stroke but mRS≤1 before onset 5. 6 ≤NIHSS≤ 16 6. Meet the clinical thrombolysis indications in the Chinese Guidelines for the Diagnosis and Treatment of Ischemic Stroke and receive reteplase intravenous thrombolysis 7. Have provided signed written informed consent from the patient or the patient's legal representative Exclusion Criteria: 1. Preoperative non-contrast head CT shows Alberta Stroke Program Early CT Score (ASPECTS) ≤ 6 2. Presence of contraindications to intravenous thrombolysis 3. Patients who have been on angiotensin-converting enzyme inhibitor (ACEI) drugs and within 5 half-lives (according to the specific drug instructions) before initiate Human Urinary Kallidinogenase treatment 4. Planed for endovascular treatment 5. Patients with fracture, claudication and other factors affecting functional outcome score upon admission 6. Use of Edaravone Injection, Edaravone Dexborneol Injection, Sublingual Edaravone Dexborneol, Butylphthalide Injection or Capsules after the onset of the current episode 7. Severe uncontrolled hypertension: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg 8. History of severe food or drug allergies, or prior allergy or intolerance to urinary kallidinogenase for injection 9. Pregnant or lactating women, or patients planning pregnancy within 90 days 10. Renal failure or severe renal impairment (creatinine clearance \< 30 mL/min) at screening 11. Liver function impairment: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal, or liver diseases (e.g., acute/chronic hepatitis, cirrhosis) 12. Heart failure (NYHA Class III or IV), unstable angina, acute myocardial infarction, severe arrhythmia, or second/third-degree cardiac conduction obstruction within 6 months before randomization 13. Drug abuse or addiction in the past year 14. Concurrent malignant tumors or severe systemic diseases with an expected survival \< 90 days 15. Severe mental disorders or dementia unable to complete the informed consent and follow-up 16. Participation in any interventional drug or device clinical trial within 3 months before screening 17. Patients deemed unsuitable for the study 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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China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033, 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?