MedTrace Logo

Sodium Sivelestat With Mechanical Thrombectomy for Acute Stroke: A Pilot Study

NCT07196605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

  • Acute Ischemic Stroke
  • Neutrophil Extracellular Traps Formation
  • Large Vessel Occlusion
  • Thrombectomy

Interventions

DRUG

Sodium Sivelestat

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 & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2026-03-01
Completion
2026-03-10

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07196605 on ClinicalTrials.gov