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New drug could boost stroke recovery by calming brain inflammation

NCT ID NCT07552610

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 868 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Gaomi People's Hospital

    RECRUITING

    Weifang, Shandong, China

  • Xuanwu Hospital, Capital Medical University.

    RECRUITING

    Beijing, China

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