Efficacy and Safety of Sodium Sivelestat as an Adjunct to Mechanical Thrombectomy in Acute Large Vessel Occlusion Stroke: A Prospective Single-Arm Exploratory Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 the standard treatment for large vessel occlusion (LVO) stroke; however, the phenomenon of futile recanalization remains common, with nearly half of patients failing to achieve favorable outcomes despite successful vessel reperfusion. Increasing evidence indicates that neutrophils and neutrophil extracellular traps (NETs) play pivotal roles in post-reperfusion inflammation, thrombosis, and microcirculatory dysfunction, contributing to thrombolysis resistance and poor prognosis. Neutrophil elastase (NE), a key component of NETs, exacerbates vascular injury and thrombus formation. Sodium sivelestat, a selective NE inhibitor, has demonstrated significant anti-inflammatory and organ-protective effects in patients with acute respiratory distress syndrome and in experimental models of cerebral ischemia. It can preserve blood-brain barrier integrity, attenuate brain edema, and improve neurological outcomes. Based on these findings, we propose a prospective, single-center, single-arm exploratory clinical trial to evaluate the efficacy and safety of sodium sivelestat as an adjunct to EVT in patients with acute LVO stroke within 24 hours of onset. The results of this study are expected to provide new clinical evidence for anti-inflammatory interventions aimed at reducing futile recanalization and improving functional outcomes in AIS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Symptoms and signs consistent with focal ischemia in the anterior or posterior circulation;

• Large vessel occlusion of the anterior or posterior circulation (internal carotid artery, M1/M2 segment of the middle cerebral artery, vertebral artery, or basilar artery) confirmed by CTA/MRA/DSA;

• Undergoing mechanical thrombectomy;

• Age ≥18 years, both male and female;

• Pre-stroke modified Rankin Scale (mRS) score ≤1;

• 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);

• National Institutes of Health Stroke Scale (NIHSS) score ≥6 at admission;

• ASPECTS ≥3 for anterior circulation occlusion, or pc-ASPECTS ≥6 for posterior circulation occlusion;

• Written informed consent provided by the patient or their legal representative.

Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University.
RECRUITING
Beijing
Time Frame
Start Date: 2025-10-28
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 20
Treatments
Experimental: Intravenous Sodium Sivelestat Group
For enrolled patients, administer intravenous sodium sivelestat as soon as possible (recommended within 2 hours). The daily dosage is 4.8 mg/kg, delivered via continuous infusion with a microinfusion pump or intravenous drip, for a total duration of 5 days.
Sponsors
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov