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Acute Ischemic StrokeNCT07196605

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

A study testing Sodium Sivelestat in people with Acute Ischemic Stroke and Neutrophil Extracellular Traps Formation, run by Xuanwu Hospital, Beijing at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sodium Sivelestat
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
28 Oct 2025to 10 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu Hospital, Capital Medical University.

    Beijing, 100053

Other trials in China

About this study

Official title: Efficacy and Safety of Sodium Sivelestat as an Adjunct to Mechanical Thrombectomy in Acute Large Vessel Occlusion Stroke: A Prospective Single-Arm Exploratory Study

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.

Being tested
Sodium Sivelestat
Keywords
Endovascular Thrombectomy, Sodium sivelestat, Neutrophil elastase
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium SivelestatDrug

    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

Study groups in NCT07196605
Study groupRoleWhat they receive
Intravenous Sodium Sivelestat GroupExperimentalFor 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.
Receives: Drug: Sodium Sivelestat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportional distribution of modified Rankin Score

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

    Measured: 90 days (±7 days) after randomization

Secondary outcomes (11)

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

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

    Measured: 90 days (±7 days) after randomization

  2. Rate of mRS score of 0-2

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

    Measured: 90 days (±7 days) after randomization

  3. Rate of mRS score of 0-3

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

    Measured: 90 days (±7 days) after randomization

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

    The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)

    Measured: 48 hours (±12 hours) after randomization

  5. Rate of early neurological improvement

    The NIHSS score decreased by ≥4 points compared with baseline

    Measured: 48 hours (±12 hours) after randomization

  6. Improvement of the NIHSS score

    The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)

    Measured: 7 days (±1 days) after randomization or discharge

  7. EQ-5D-5L

    The EQ-5D 5-Levels (EQ-5D-5L) range from 5 (no problems) to 25 (extreme problems), which deceased patients have a utility of 0.

    Measured: 90 days (±7 days) after randomization

  8. Barthel Index

    The Barthel Index range from 0 (severe disability) to 100 (no disability)

    Measured: 90 days (±7 days) after randomization

  9. Rate of intracranial hemorrhage (ICH)

    Any intracranial hemorrhage confirmed by imaging

    Measured: Within 48 hours after randomization

  10. Rate of symptomatic intracranial hemorrhage (sICH)

    The sICH was assessed based on the Heidelberg Bleeding Classification, defined as 1) ≥4 points total NIHSS at the time of diagnosis compared to immediately before worsening; 2) ≥2 point in one NIHSS category. The rationale for this is to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; 3) Leading to intubation/hemicraniectomy/EVD placement or other major medical/surgical intervention; 4) Absence of alternative explanation for deterioration.

    Measured: Within 48 hours after randomization

  11. All-cause mortality

    Death defined as a mRS score of 6

    Measured: 90 days (±7 days) after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2025
  2. Study start28 Oct 2025
  3. Primary completion1 Mar 2026
  4. Study completion10 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07196605
Sponsor's protocol ID
IAT-TOP2 Pilot
Status last verified
Sep 2025
First submitted
21 Sep 2025
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sodium Sivelestat in people with Acute Ischemic Stroke and Neutrophil Extracellular Traps Formation, run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportional distribution of modified Rankin Score (time frame: 90 days (±7 days) after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07196605.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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