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

NCT07196605 | Completed DMC

• 1 other identifier: IAT-TOP2 Pilot
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endovascular Thrombectomy; Sodium sivelestat; Neutrophil elastase

Outcome Measures

Primary Outcomes (1)

• Proportional distribution of modified Rankin Score

  The mRS score range from 0 (no disability) to 6 (death)

  90 days (±7 days) after randomization

Secondary Outcomes (11)

• Rate of modified Rankin Scale (mRS) score of 0-1

  90 days (±7 days) after randomization

• Rate of mRS score of 0-2

  90 days (±7 days) after randomization

• Rate of mRS score of 0-3

  90 days (±7 days) after randomization

• Improvement of the National Institutes of Health Stroke Scale (NIHSS) score

  48 hours (±12 hours) after randomization

• Rate of early neurological improvement

  48 hours (±12 hours) after randomization

Study Arms (1)

Intravenous Sodium Sivelestat Group

EXPERIMENTAL

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.

Drug: Sodium Sivelestat

Interventions

Sodium Sivelestat DRUG

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

Intravenous Sodium Sivelestat Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Simultaneous acute occlusion of both anterior and posterior circulation or bilateral hemispheric large vessel occlusions;
• Complete clinical recovery at the end of EVT procedure;
• Arterial dissection or intraoperative hemorrhage indicated by post-thrombectomy DSA;
• Sedated and intubated patients without baseline NIHSS assessment;
• Seizure at stroke onset interfering with baseline NIHSS assessment;
• Bilateral fixed dilated pupils;
• Severe allergy or absolute contraindication to sodium sivelestat;
• Severe allergy or absolute contraindication to iodinated contrast agents;
• Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, uncontrolled despite antihypertensive therapy;
• Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L);
• Platelet count \<50×10⁹/L;
• Congenital or acquired bleeding diathesis, coagulation factor deficiency, or current use of oral anticoagulants with INR \>1.7;
• Severe renal impairment, defined as serum creatinine \>3.0 mg/dl (265.2 μmol/L), GFR \<30 ml/min, or requirement for hemodialysis/peritoneal dialysis;
• Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patient);
• Suspected vasculitis or septic embolism;

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University.

Beijing, 100053, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: September 29, 2025
• Study Start: October 28, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 10, 2026
• Last Updated: March 24, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)