New drug could boost stroke recovery by calming brain inflammation
NCT ID NCT07552610
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether the drug sivelestat sodium, given alongside standard clot-removal surgery, can help people recover better after a major stroke. The trial will include 868 adults aged 18-80 with large-vessel blockage in the front part of the brain. The goal is to see if the drug reduces inflammation and leads to less disability.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sivelestat sodium
- What this could lead to
- If it works, this could reduce disability after stroke by preventing further brain damage from inflammation.
- What could go wrong
- This is an early-stage trial with no phase specified, so results are uncertain. The drug may not improve outcomes or could cause side effects.
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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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 868 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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May 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.
- Ages
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18 to 80 years
- 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.Symptoms and signs consistent with focal ischemia in the anterior circulation; * 2.Large vessel occlusion of the anterior circulation (internal carotid artery, M1/M2 segment of the middle cerebral artery) confirmed by CTA/MRA/DSA; * 3.Undergoing mechanical thrombectomy; * 4.Age between 18-80 years, both male and female; * 5.Pre-stroke modified Rankin Scale (mRS) score ≤1; * 6.Time from symptom onset to thrombectomy ≤24 hours, including wake-up stroke or unwitnessed stroke; symptom onset is defined as the "last known well" (LKW); * 7.National Institutes of Health Stroke Scale (NIHSS) score ≥6 at admission; * 8.ASPECTS ≥3 for anterior circulation occlusion; * 9.Written informed consent provided by the patient or their legal representative. Exclusion Criteria: * 1.Simultaneous acute occlusion of both the anterior and posterior circulation, or bilateral acute large-vessel occlusion in the anterior circulation; * 2.Failure to obtain a baseline NIHSS score before sedation or intubation by a neurologist or emergency physician; * 3.Seizure at stroke onset that precludes assessment of the baseline NIHSS score; * 4.Bilateral dilated pupils; * 5.Known allergy to sivelestat sodium or any of its excipients; * 6.Severe allergy or absolute contraindication to iodinated contrast agents; * 7.Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg that cannot be controlled with antihypertensive therapy; * 8.Blood glucose \<50 mg/dL (2.8 mmol/L) or \>400 mg/dL (22.2 mmol/L); * 9.Platelet count \<50 \* 10⁹/L; * 10.Hereditary or acquired bleeding tendency, coagulation factor deficiency, current oral anticoagulant use with INR \>1.7, or oral anticoagulant treatment within the previous 48 hours; * 11.Severe renal failure, defined as serum creatinine \>3.0 mg/dL (265.2 μmol/L), glomerular filtration rate (GFR) \<30 mL/min, or requirement for hemodialysis or peritoneal dialysis; * 12.Inability to complete the 90-day follow-up (e.g., no fixed residence or overseas patients); * 13.Suspected vasculitis or septic embolism; * 14.Suspected aortic dissection; * 15.Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, tumor, or arteriovenous malformation; * 16.Significant mass effect with midline shift; * 17.Evidence of internal carotid artery dissection causing flow limitation; * 18.Neurological disease or psychiatric disorder that may interfere with evaluation of the patient's condition; * 19.Pregnant or breastfeeding women; * 20.Confirmed rheumatic or autoimmune disease with long-term use of immunosuppressants or corticosteroids; * 21.Current treatment with chemotherapy or other immunomodulatory agents (e.g., recombinant human granulocyte colony-stimulating factor, Xuebijing, or ulinastatin); * 22.Participation in another clinical trial that may interfere with the results of this study; * 23.Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation or may pose a significant risk to the patient.
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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
2 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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Gaomi People's Hospital
RECRUITINGWeifang, Shandong, China
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Xuanwu Hospital, Capital Medical University.
RECRUITINGBeijing, China
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- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better