Status:
RECRUITING
Sodium Sivelestat With Mechanical Thrombectomy for Acute Stroke: A Pilot Study
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Acute Ischemic Stroke
Neutrophil Extracellular Traps Formation
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Suspected aortic dissection;
- Pre-existing neurological or psychiatric disorders interfering with stroke assessment;
- Pregnancy or lactation;
- Confirmed rheumatic/autoimmune disease with long-term use of immunosuppressants or corticosteroids;
- Current treatment with chemotherapy or other immunomodulatory agents (e.g., recombinant human granulocyte colony-stimulating factor, Xuebijing, ulinastatin, etc.);
- Participation in another clinical trial that may interfere with study outcomes;
- Any other condition that investigators deem unsuitable for participation or that may pose significant risk to the patient.
Key Trial Info
Start Date :
October 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07196605
Start Date
October 28 2025
End Date
June 1 2026
Last Update
December 9 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University.
Beijing, China, 100053