Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT07196605
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sodium Sivelestat With Mechanical Thrombectomy for Acute Stroke: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2025-09-21', 'studyFirstSubmitQcDate': '2025-09-21', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportional distribution of modified Rankin Score', 'timeFrame': '90 days (±7 days) after randomization', 'description': 'The mRS score range from 0 (no disability) to 6 (death)'}], 'secondaryOutcomes': [{'measure': 'Rate of modified Rankin Scale (mRS) score of 0-1', 'timeFrame': '90 days (±7 days) after randomization', 'description': 'The mRS score range from 0 (no disability) to 6 (death)'}, {'measure': 'Rate of mRS score of 0-2', 'timeFrame': '90 days (±7 days) after randomization', 'description': 'The mRS score range from 0 (no disability) to 6 (death)'}, {'measure': 'Rate of mRS score of 0-3', 'timeFrame': '90 days (±7 days) after randomization', 'description': 'The mRS score range from 0 (no disability) to 6 (death)'}, {'measure': 'Improvement of the National Institutes of Health Stroke Scale (NIHSS) score', 'timeFrame': '48 hours (±12 hours) after randomization', 'description': 'The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)'}, {'measure': 'Rate of early neurological improvement', 'timeFrame': '48 hours (±12 hours) after randomization', 'description': 'The NIHSS score decreased by ≥4 points compared with baseline'}, {'measure': 'Improvement of the NIHSS score', 'timeFrame': '7 days (±1 days) after randomization or discharge', 'description': 'The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)'}, {'measure': 'EQ-5D-5L', 'timeFrame': '90 days (±7 days) after randomization', 'description': '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.'}, {'measure': 'Barthel Index', 'timeFrame': '90 days (±7 days) after randomization', 'description': 'The Barthel Index range from 0 (severe disability) to 100 (no disability)'}, {'measure': 'Rate of intracranial hemorrhage (ICH)', 'timeFrame': 'Within 48 hours after randomization', 'description': 'Any intracranial hemorrhage confirmed by imaging'}, {'measure': 'Rate of symptomatic intracranial hemorrhage (sICH)', 'timeFrame': 'Within 48 hours after randomization', 'description': '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.'}, {'measure': 'All-cause mortality', 'timeFrame': '90 days (±7 days) after randomization', 'description': 'Death defined as a mRS score of 6'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endovascular Thrombectomy', 'Sodium sivelestat', 'Neutrophil elastase'], 'conditions': ['Acute Ischemic Stroke', 'Neutrophil Extracellular Traps Formation', 'Large Vessel Occlusion', 'Thrombectomy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Symptoms and signs consistent with focal ischemia in the anterior or posterior circulation;\n2. 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;\n3. Undergoing mechanical thrombectomy;\n4. Age ≥18 years, both male and female;\n5. Pre-stroke modified Rankin Scale (mRS) score ≤1;\n6. 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);\n7. National Institutes of Health Stroke Scale (NIHSS) score ≥6 at admission;\n8. ASPECTS ≥3 for anterior circulation occlusion, or pc-ASPECTS ≥6 for posterior circulation occlusion;\n9. Written informed consent provided by the patient or their legal representative.\n\nExclusion Criteria:\n\n1. Simultaneous acute occlusion of both anterior and posterior circulation or bilateral hemispheric large vessel occlusions;\n2. Complete clinical recovery at the end of EVT procedure;\n3. Arterial dissection or intraoperative hemorrhage indicated by post-thrombectomy DSA;\n4. Sedated and intubated patients without baseline NIHSS assessment;\n5. Seizure at stroke onset interfering with baseline NIHSS assessment;\n6. Bilateral fixed dilated pupils;\n7. Severe allergy or absolute contraindication to sodium sivelestat;\n8. Severe allergy or absolute contraindication to iodinated contrast agents;\n9. Systolic blood pressure \\>185 mmHg or diastolic blood pressure \\>110 mmHg, uncontrolled despite antihypertensive therapy;\n10. Blood glucose \\<50 mg/dl (2.8 mmol/L) or \\>400 mg/dl (22.2 mmol/L);\n11. Platelet count \\<50×10⁹/L;\n12. Congenital or acquired bleeding diathesis, coagulation factor deficiency, or current use of oral anticoagulants with INR \\>1.7;\n13. 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;\n14. Inability to complete 90-day follow-up (e.g., no fixed residence, overseas patient);\n15. Suspected vasculitis or septic embolism;\n16. Suspected aortic dissection;\n17. Pre-existing neurological or psychiatric disorders interfering with stroke assessment;\n18. Pregnancy or lactation;\n19. Confirmed rheumatic/autoimmune disease with long-term use of immunosuppressants or corticosteroids;\n20. Current treatment with chemotherapy or other immunomodulatory agents (e.g., recombinant human granulocyte colony-stimulating factor, Xuebijing, ulinastatin, etc.);\n21. Participation in another clinical trial that may interfere with study outcomes;\n22. Any other condition that investigators deem unsuitable for participation or that may pose significant risk to the patient.'}, 'identificationModule': {'nctId': 'NCT07196605', 'briefTitle': 'Sodium Sivelestat With Mechanical Thrombectomy for Acute Stroke: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Efficacy and Safety of Sodium Sivelestat as an Adjunct to Mechanical Thrombectomy in Acute Large Vessel Occlusion Stroke: A Prospective Single-Arm Exploratory Study', 'orgStudyIdInfo': {'id': 'IAT-TOP 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous Sodium Sivelestat Group', 'description': '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.', 'interventionNames': ['Drug: Sodium Sivelestat']}], 'interventions': [{'name': 'Sodium Sivelestat', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Intravenous Sodium Sivelestat Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liqun Jiao, Dr.', 'role': 'CONTACT', 'email': 'liqunjiao@sina.cn', 'phone': '+86 13911224991'}], 'facility': 'Xuanwu Hospital, Capital Medical University.', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}