Sivelestat added to endovascular clot retrieval for acute anterior circulation stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial investigates the addition of the neutrophil elastase inhibitor sivelestat sodium to the standard endovascular thrombectomy in patients with acute anterior circulation large-vessel occlusion. Eligible participants are adults aged 18–80 who undergo mechanical thrombectomy within 24 hours of onset and have a pretreatment mRS of 0–1. The study compares sivelestat sodium versus placebo as an adjunct therapy, focusing on inflammatory pathways related to NETs and neutrophil elastase, with safety and functional outcomes as key endpoints. The design includes multiple sites in China and uses standard imaging and clinical criteria to identify eligible patients. Results could inform whether NE inhibition improves reperfusion success, reduces microvascular injury, and enhances functional recovery after thrombectomy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Gaomi People's Hospital
  Weifang, Shandong, China Recruiting
• Xuanwu Hospital, Capital Medical University.
  Beijing, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.