Acute Ischemic StrokeNCT07552610
Sivelestat Sodium as an Adjunct to Endovascular Thrombectomy for Acute Anterior Circulation Large-Vessel Occlusion
A study testing Sivelestat sodium and Endovascular Thrombectomy in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Xuanwu Hospital, Beijing at 2 sites in China.
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 a standard treatment for large vessel occlusion (LVO) stroke; however, "futile recanalization" remains common, with many patients failing to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy
- What is being tested?
- Sivelestat sodium and Endovascular Thrombectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 868 participants
- Where
- 2 sitesChina
- Study dates
- 22 Jun 2026to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Symptoms and signs consistent with focal ischemia in the anterior circulation;
- 2.Large vessel occlusion of the anterior circulation (internal carotid artery, M1/M2 segment of the middle cerebral artery) confirmed by CTA/MRA/DSA;
- 3.Undergoing mechanical thrombectomy;
- 4.Age between 18-80 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);
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- 7.National Institutes of Health Stroke Scale (NIHSS) score ≥6 at admission;
- 8.ASPECTS ≥3 for anterior circulation occlusion;
- 9.Written informed consent provided by the patient or their legal representative.
Who cannot join
- 1．Simultaneous acute occlusion of both the anterior and posterior circulation, or bilateral acute large-vessel occlusion in the anterior circulation;
- 2．Failure to obtain a baseline NIHSS score before sedation or intubation by a neurologist or emergency physician;
- 3．Seizure at stroke onset that precludes assessment of the baseline NIHSS score;
- 4．Bilateral dilated pupils;
- 5．Known allergy to sivelestat sodium or any of its excipients;
- 6．Severe allergy or absolute contraindication to iodinated contrast agents;
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- 7．Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg that cannot be controlled with antihypertensive therapy;
- 8．Blood glucose <50 mg/dL (2.8 mmol/L) or >400 mg/dL (22.2 mmol/L);
- 9．Platelet count <50 * 10⁹/L;
- 10．Hereditary or acquired bleeding tendency, coagulation factor deficiency, current oral anticoagulant use with INR >1.7, or oral anticoagulant treatment within the previous 48 hours;
- 11．Severe renal failure, defined as serum creatinine >3.0 mg/dL (265.2 μmol/L), glomerular filtration rate (GFR) <30 mL/min, or requirement for hemodialysis or peritoneal dialysis;
- 12．Inability to complete the 90-day follow-up (e.g., no fixed residence or overseas patients);
- 13．Suspected vasculitis or septic embolism;
- 14．Suspected aortic dissection;
- 15．Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, tumor, or arteriovenous malformation;
- 16．Significant mass effect with midline shift;
- 17．Evidence of internal carotid artery dissection causing flow limitation;
- 18．Neurological disease or psychiatric disorder that may interfere with evaluation of the patient's condition;
- 19．Pregnant or breastfeeding women;
- 20．Confirmed rheumatic or autoimmune disease with long-term use of immunosuppressants or corticosteroids;
- 21．Current treatment with chemotherapy or other immunomodulatory agents (e.g., recombinant human granulocyte colony-stimulating factor, Xuebijing, or ulinastatin);
- 22．Participation in another clinical trial that may interfere with the results of this study;
- 23．Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation or may pose a significant risk to the patient.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University.
Beijing
Liqun Jiao, Dr., +86 13911224991, liqunjiao@sina.cn
- Recruiting
Gaomi People's Hospital
Weifang, Shandong
Shaoguang Wu, MD., +8613563617023, wushaoguang1999@163.com
About this study
Official title: Efficacy and Safety of Sivelestat Sodium as an Adjunct to Endovascular Thrombectomy in Acute Anterior Circulation Large-Vessel Occlusion: A Multicenter, Randomized, Double-Blind, Placebo-Controlled 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 a standard treatment for large vessel occlusion (LVO) stroke; however, "futile recanalization" remains common, with many patients failing to achieve favorable functional outcomes despite successful vessel reperfusion. Increasing evidence indicates that neutrophils and neutrophil extracellular traps (NETs) play important roles in post-reperfusion inflammation, thrombosis, and microcirculatory dysfunction, which may contribute to thrombolysis resistance and poor prognosis. Neutrophil elastase (NE), a key component associated with NETs, may further aggravate vascular injury and thrombus formation.
Sivelestat Sodium is a selective NE inhibitor that has demonstrated anti-inflammatory and organ-protective effects in patients with acute respiratory distress syndrome and in experimental models of cerebral ischemia. It may help preserve blood-brain barrier integrity, reduce brain edema, and improve neurological outcomes. Based on these findings, this study is designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of sivelestat sodium as an adjunct to EVT in patients with acute anterior circulation large-vessel occlusive stroke within 24 hours of onset. The results of this study are expected to provide further clinical evidence for anti-inflammatory adjunctive treatment strategies aimed at reducing futile recanalization and improving functional outcomes in AIS.
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy, Neutrophil Extracellular Trap Formation
- Being tested
- Sivelestat sodium, Placebo, Endovascular Thrombectomy
- Keywords
- Endovascular Thrombectomy, Sivelestat Sodium, 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.
Sivelestat sodiumDrug
Sivelestat sodium is a selective neutrophil elastase inhibitor administered as an adjunctive treatment to endovascular thrombectomy in this study. Treatment will be initiated within 2 hours after randomization and continued once daily until Day 7 after randomization or hospital discharge, whichever occurs first. The daily dose is 4.8 mg/kg, administered by continuous intravenous infusion using a microinfusion pump or by intravenous drip.
PlaceboDrug
The placebo does not contain sivelestat sodium and consists of the same excipients as the investigational product without the active ingredient. It will be administered in the same manner, timing, and schedule as sivelestat sodium, beginning within 2 hours after randomization and continuing once daily until Day 7 after randomization or hospital discharge, whichever occurs first, in order to maintain blinding.
Endovascular ThrombectomyProcedure or surgery
Endovascular thrombectomy will be performed according to standard clinical practice using NMPA-approved thrombectomy devices. First-line techniques may include aspiration thrombectomy, stent retriever thrombectomy, or a combined approach, with rescue procedures permitted when necessary at the investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Sivelestat Sodium + Endovascular Thrombectomy | Experimental | Participants randomized to the experimental arm will receive sivelestat sodium injection in addition to standard endovascular thrombectomy (EVT). Sivelestat sodium will be initiated within 2 hours after randomization and administered once daily until Day 7 after randomization or hospital discharge, whichever occurs first. The daily dose is 4.8 mg/kg, given by continuous infusion using a microinfusion pump or by intravenous drip. EVT will be performed according to standard clinical practice using NMPA-approved thrombectomy devices. Receives: Drug: Sivelestat sodium; Procedure: Endovascular Thrombectomy |
| Placebo + Endovascular Thrombectomy | Placebo comparator | Participants randomized to the control arm will receive placebo in addition to standard EVT. The placebo does not contain sivelestat sodium and will be administered in the same manner as the investigational product, beginning within 2 hours after randomization and continuing once daily until Day 7 after randomization or hospital discharge, whichever occurs first. The placebo is matched to sivelestat sodium in appearance, packaging, labeling, and method of administration to maintain blinding. EVT will be performed according to standard clinical practice. Receives: Drug: Placebo; Procedure: Endovascular Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of modified Rankin Scale (mRS) score of 0-2
The mRS score range from 0 (no disability) to 6 (death)
Measured: 90 days (±7 days) after randomization
Secondary outcomes (11)
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
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
Proportional distribution of modified Rankin Score
The mRS score range from 0 (no disability) to 6 (death)
Measured: 90 days (±7 days) after randomization
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
Rate of early neurological improvement
Early neurological improvement, defined as an NIHSS score of 0-1 at 48 hours or a reduction of ≥4 points from baseline.
Measured: 48 hours (±12 hours) after randomization
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
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
Barthel Index
The Barthel Index range from 0 (severe disability) to 100 (no disability)
Measured: 90 days (±7 days) after randomization
Rate of intracranial hemorrhage (ICH)
Any intracranial hemorrhage confirmed by imaging
Measured: Within 48 hours after randomization
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
All-cause mortality
Death is 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.
- First posted27 Apr 2026
- Study start22 Jun 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 868 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552610
- Sponsor's protocol ID
- IAT-TOP II
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sivelestat Sodium as an Adjunct to Endovascular Thrombectomy in Acute Anterior Circulation Large-Vessel Occlusion: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07552610
- Acronym / sponsor ID
- IAT-TOP II
- Conditions
- Acute Ischemic Stroke, Large Vessel Occlusion, Thrombectomy, Neutrophil Extracellular Trap Formation
- Keywords
- Endovascular Thrombectomy, Sivelestat Sodium, Neutrophil elastase
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 868 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 a standard treatment for large vessel occlusion (LVO) stroke; however, "futile recanalization" remains common, with many patients failing to achieve favorable functional outcomes despite successful vessel reperfusion. Increasing evidence indicates that neutrophils and neutrophil extracellular traps (NETs) play important roles in post-reperfusion inflammation, thrombosis, and microcirculatory dysfunction, which may contribute to thrombolysis resistance and poor prognosis. Neutrophil elastase (NE), a key component associated with NETs, may further aggravate vascular injury and thrombus formation.
Sivelestat Sodium is a selective NE inhibitor that has demonstrated anti-inflammatory and organ-protective effects in patients with acute respiratory distress syndrome and in experimental models of cerebral ischemia. It may help preserve blood-brain barrier integrity, reduce brain edema, and improve neurological outcomes. Based on these findings, this study is designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of sivelestat sodium as an adjunct to EVT in patients with acute anterior circulation large-vessel occlusive stroke within 24 hours of onset. The results of this study are expected to provide further clinical evidence for anti-inflammatory adjunctive treatment strategies aimed at reducing futile recanalization and improving functional outcomes in AIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sivelestat Sodium + Endovascular Thrombectomy | Experimental | Drug: Sivelestat sodium, Procedure: Endovascular ThrombectomyParticipants randomized to the experimental arm will receive sivelestat sodium injection in addition to standard endovascular thrombectomy (EVT). Sivelestat sodium will be initiated within 2 hours after randomization and administered once daily until Day 7 after randomization or hospital discharge, whichever occurs first. The daily dose is 4.8 mg/kg, given by continuous infusion using a microinfusion pump or by intravenous drip. EVT will be performed according to standard clinical practice using NMPA-approved thrombectomy devices. |
| Placebo + Endovascular Thrombectomy | Placebo comparator | Drug: Placebo, Procedure: Endovascular ThrombectomyParticipants randomized to the control arm will receive placebo in addition to standard EVT. The placebo does not contain sivelestat sodium and will be administered in the same manner as the investigational product, beginning within 2 hours after randomization and continuing once daily until Day 7 after randomization or hospital discharge, whichever occurs first. The placebo is matched to sivelestat sodium in appearance, packaging, labeling, and method of administration to maintain blinding. EVT will be performed according to standard clinical practice. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1.Symptoms and signs consistent with focal ischemia in the anterior circulation;
- 2.Large vessel occlusion of the anterior circulation (internal carotid artery, M1/M2 segment of the middle cerebral artery) confirmed by CTA/MRA/DSA;
- 3.Undergoing mechanical thrombectomy;
- 4.Age between 18-80 years, both male and female;
- 5.Pre-stroke modified Rankin Scale (mRS) score ≤1;
Key exclusion criteria (23 listed)
- 1．Simultaneous acute occlusion of both the anterior and posterior circulation, or bilateral acute large-vessel occlusion in the anterior circulation;
- 2．Failure to obtain a baseline NIHSS score before sedation or intubation by a neurologist or emergency physician;
- 3．Seizure at stroke onset that precludes assessment of the baseline NIHSS score;
- 4．Bilateral dilated pupils;
- 5．Known allergy to sivelestat sodium or any of its excipients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sivelestat sodiumSivelestat sodium is a selective neutrophil elastase inhibitor administered as an adjunctive treatment to endovascular thrombectomy in this study. Treatment will be initiated within 2 hours after randomization and continued once daily until Day 7 after randomization or hospital discharge, whichever occurs first. The daily dose is 4.8 mg/kg, administered by continuous intravenous infusion using a microinfusion pump or by intravenous drip. | Drug | Sivelestat Sodium + Endovascular Thrombectomy |
| PlaceboThe placebo does not contain sivelestat sodium and consists of the same excipients as the investigational product without the active ingredient. It will be administered in the same manner, timing, and schedule as sivelestat sodium, beginning within 2 hours after randomization and continuing once daily until Day 7 after randomization or hospital discharge, whichever occurs first, in order to maintain blinding. | Drug | Placebo + Endovascular Thrombectomy |
| Endovascular ThrombectomyEndovascular thrombectomy will be performed according to standard clinical practice using NMPA-approved thrombectomy devices. First-line techniques may include aspiration thrombectomy, stent retriever thrombectomy, or a combined approach, with rescue procedures permitted when necessary at the investigator's discretion. | Procedure or surgery | Placebo + Endovascular Thrombectomy, Sivelestat Sodium + Endovascular Thrombectomy |
Primary outcome
Rate of modified Rankin Scale (mRS) score of 0-2
Time frame: 90 days (±7 days) after randomization
The mRS score range from 0 (no disability) to 6 (death)
11 secondary outcomes
Rate of modified Rankin Scale (mRS) score of 0-1
Time frame: 90 days (±7 days) after randomization
Rate of mRS score of 0-3
Time frame: 90 days (±7 days) after randomization
Proportional distribution of modified Rankin Score
Time frame: 90 days (±7 days) after randomization
Improvement of the National Institutes of Health Stroke Scale (NIHSS) score
Time frame: 48 hours (±12 hours) after randomization
Rate of early neurological improvement
Time frame: 48 hours (±12 hours) after randomization
Improvement of the NIHSS score
Time frame: 7 days (±1 days) after randomization or discharge
EQ-5D-5L
Time frame: 90 days (±7 days) after randomization
Barthel Index
Time frame: 90 days (±7 days) after randomization
Rate of intracranial hemorrhage (ICH)
Time frame: Within 48 hours after randomization
Rate of symptomatic intracranial hemorrhage (sICH)
Time frame: Within 48 hours after randomization
All-cause mortality
Time frame: 90 days (±7 days) after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sivelestat sodium and Endovascular Thrombectomy in people with Acute Ischemic Stroke and Large Vessel Occlusion, run by Xuanwu Hospital, Beijing at 2 sites 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 23 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of modified Rankin Scale (mRS) score of 0-2 (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?
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 25 Jun 2026.