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New drug shows promise in stroke recovery trial

NCT ID NCT07196605

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

20 people

The number who actually took part.

Started

Oct 2025

Finished

Mar 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Xuanwu Hospital, Capital Medical University.

    Beijing, 100053, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.