NCT07552610Recruiting
Sivelestat Sodium as an Adjunct to Endovascular Thrombectomy for Acute Anterior Circulation Large-Vessel Occlusion
Efficacy and Safety of Sivelestat Sodium as an Adjunct to Endovascular Thrombectomy in Acute Anterior Circulation Large-Vessel Occlusion: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
Stroke remains a major global health burden, with acute ischemic stroke (AIS) accounting for more than 65% of all cases. Endovascular thrombectomy (EVT) has been established as a standard treatment for large vessel occlusion (LVO) stroke; however, "futile recanalization" remains common, with many patients failing to achieve favorable functional outcomes despite successful vessel reperfusion. Increasing evidence indicates that neutrophils and neutrophil extracellular traps (NETs) play important roles in post-reperfusion inflammation, thrombosis, and microcirculatory dysfunction, which may contribute to thrombolysis resistance and poor prognosis. Neutrophil elastase (NE), a key component associated with NETs, may further aggravate vascular injury and thrombus formation. Sivelestat Sodium is a selective NE inhibitor that has demonstrated anti-inflammatory and organ-protective effects in patients with acute respiratory distress syndrome and in experimental models of cerebral ischemia. It may help preserve blood-brain barrier integrity, reduce brain edema, and improve neurological outcomes. Based on these findings, this study is designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of sivelestat sodium as an adjunct to EVT in patients with acute anterior circulation large-vessel occlusive stroke within 24 hours of onset. The results of this study are expected to provide further clinical evidence for anti-inflammatory adjunctive treatment strategies aimed at reducing futile recanalization and improving functional outcomes in AIS.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 868 (estimated)
- First submitted
- 20 Apr 2026
- Start date
- 22 Jun 2026
- Primary completion date
- 31 May 2029
- Lead sponsor
- Xuanwu Hospital, Beijing
- Diseases
- Stroke
- NCT number
- NCT07552610
What you commit to
- Study type: Interventional
- Planned participants: 868
- From 22 Jun 2026 to the primary completion date, 31 May 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 7.Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg that cannot be controlled with antihypertensive therapy;
- 21.Current treatment with chemotherapy or other immunomodulatory agents (e.g., recombinant human granulocyte colony-stimulating factor, Xuebijing, or ulinastatin);
Other illness
- 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;
- 6.Severe allergy or absolute contraindication to iodinated contrast agents;
- 15.Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, tumor, or arteriovenous malformation;
- 18.Neurological disease or psychiatric disorder that may interfere with evaluation of the patient's condition;
- 20.Confirmed rheumatic or autoimmune disease with long-term use of immunosuppressants or corticosteroids;
- 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.
Lab values
- 5.Known allergy to sivelestat sodium or any of its excipients;
- 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;
Other
- 1.Simultaneous acute occlusion of both the anterior and posterior circulation, or bilateral acute large-vessel occlusion in the anterior circulation;
- 4.Bilateral dilated pupils;
- 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;
- 16.Significant mass effect with midline shift;
- 17.Evidence of internal carotid artery dissection causing flow limitation;
- 19.Pregnant or breastfeeding women;
- 22.Participation in another clinical trial that may interfere with the results of this study;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Gaomi People's Hospital Coordinator of this site? Confirm its status | Weifang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.