New drug shows promise in stroke recovery trial
NCT ID NCT07196605
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding sodium sivelestat, a drug that reduces inflammation, to standard mechanical thrombectomy could improve outcomes in 20 stroke patients with large vessel occlusion. The drug aims to prevent 'futile recanalization,' where blood flow is restored but patients still do poorly. Results are expected to provide early evidence for a new anti-inflammatory approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sodium sivelestat
- What this could lead to
- If it works, this could point toward a new anti-inflammatory treatment to improve recovery after stroke thrombectomy.
- What could go wrong
- This is a very small, early exploratory study with only 20 patients and no comparison group, so results may not be reliable or generalizable.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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20 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Symptoms and signs consistent with focal ischemia in the anterior or posterior circulation; 2. 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; 3. Undergoing mechanical thrombectomy; 4. Age ≥18 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, or pc-ASPECTS ≥6 for posterior circulation occlusion; 9. Written informed consent provided by the patient or their legal representative. Exclusion Criteria: 1. Simultaneous acute occlusion of both anterior and posterior circulation or bilateral hemispheric large vessel occlusions; 2. Complete clinical recovery at the end of EVT procedure; 3. Arterial dissection or intraoperative hemorrhage indicated by post-thrombectomy DSA; 4. Sedated and intubated patients without baseline NIHSS assessment; 5. Seizure at stroke onset interfering with baseline NIHSS assessment; 6. Bilateral fixed dilated pupils; 7. Severe allergy or absolute contraindication to sodium sivelestat; 8. Severe allergy or absolute contraindication to iodinated contrast agents; 9. Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, uncontrolled despite antihypertensive therapy; 10. Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L); 11. Platelet count \<50×10⁹/L; 12. Congenital or acquired bleeding diathesis, coagulation factor deficiency, or current use of oral anticoagulants with INR \>1.7; 13. 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; 14. Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patient); 15. Suspected vasculitis or septic embolism; 16. Suspected aortic dissection; 17. Pre-existing neurological or psychiatric disorders interfering with stroke assessment; 18. Pregnancy or lactation; 19. Confirmed rheumatic/autoimmune disease with long-term use of immunosuppressants or corticosteroids; 20. Current treatment with chemotherapy or other immunomodulatory agents (e.g., recombinant human granulocyte colony-stimulating factor, Xuebijing, ulinastatin, etc.); 21. Participation in another clinical trial that may interfere with study outcomes; 22. Any other condition that investigators deem unsuitable for participation or that may pose significant risk to the patient.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Xuanwu Hospital, Capital Medical University.
Beijing, 100053, China
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Other studies related to the condition(s) this trial covers.
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