Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT07141303
Status:
RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1060}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shift in the distribution of mRS scores', 'timeFrame': '90 days'}, {'measure': 'Incidence of symptomatic intracranial hemorrhage', 'timeFrame': '48 hours'}, {'measure': 'Mortality', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'The proportion of mRS score 0 to 4', 'timeFrame': '90 days'}, {'measure': 'The proportion of mRS score 0 to 3', 'timeFrame': '90 days'}, {'measure': 'The proportion of mRS score 0 to 2', 'timeFrame': '90 days'}, {'measure': 'mRS scores', 'timeFrame': '1 year'}, {'measure': 'The incidence of malignant brain edema', 'timeFrame': 'within 48 hours'}, {'measure': 'Changes of NIHSS score', 'timeFrame': '5-7 days after surgery'}, {'measure': 'EQ-5D scale score', 'timeFrame': '90 days'}, {'measure': 'EQ-5D scale score', 'timeFrame': '1 year'}, {'measure': 'Proportion of patients with any radiologic intracranial haemorrhage', 'timeFrame': 'within 48 hours after treatment'}, {'measure': 'Proportion of patients with pneumonia', 'timeFrame': 'within 7 days after the treatment'}, {'measure': 'Proportion of patients with gastrointestinal haemorrhage', 'timeFrame': 'within 7 days after treatment'}, {'measure': 'Incidence of non-hemorrhagic serious adverse events', 'timeFrame': 'within 7 days after treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of IMPACT-LVO trial is to investigate the efficacy and safety of early adjunctive intra-arterial combined with intravenous administration methylprednisolone sodium succinate after successful endovascular thrombectomy in anterior circulation large vessel occlusion patients.\n\nThis is a multicenter, randomized, double-blind, placebo-controlled trial. Acute ischemia stroke patients with anterior circulation large vessel occlusion within 24 hours from last known well will be screened for this trial. Successful recanalization after mechanical thrombectomy (eTICI 2b-3) patients will be randomized 1:1 to either methylprednisolone sodium succinate group or placebo group. The methylprednisolone sodium succinate group patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days. The placebo group patients will receive intra-arterial and intravenous sterile water for injection.\n\nThe shift on modified Rankin Scale score is designed to detect in the present trial. A sample size of n = 1010 patients (n=505 per group) is required. The intention-to-treat principle will be applied to the primary analysis, therefore, to safeguard against dilution of the treatment effect associated with an approximate 5% non-adherence rate (due to loss to follow-up, consent withdrawal and other reasons), we planned to enrol n=1060 patients (n=530 per group) for this study. The findings of IMPACT-LVO are likely to have a direct impact on clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-80 years old; 2) The time from onset to randomization was within 24 hours; 3) Large vessel occlusive stroke in the anterior circulation confirmed by CTA/MRA/DSA (Including intracranial segment of internal carotid artery, M1 or M2 segment of middle cerebral artery) and the vessel responsible for the signs and symptoms of acute ischemic stroke; 4) NIHSS score \\>= 6 points 5) Alberta Stroke Program Early Diagnosis (ASPECTS) score of NCCT \\>=3; 6) Successful endovascular thrombectomy (eTICI 2b50-3) 7) Written informed consent signed by patients or their family members\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage confirmed by computed tomography (CT) or magnetic resonance imaging (MRI);\n2. Prestroke mRS score \\>= 2\n3. pregnant or lactating patients\n4. Allergy to iodinated contrast media, or methylprednisolone sodium succinate\n5. Participating in other clinical research;\n6. Inherited/acquired hemorrhagic diathesis (coagulation factor deficiency) or oral anticoagulation with international normalized ratio (INR) \\>1.7\n7. History of major bleeding within the past 1 month (gastrointestinal/genitourinary hemorrhage)\n8. Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \\< 30ml/min/1.73m\\^2 or serum creatinine \\> 220μmol/L (2.5mg/dl));\n9. Terminal illness with life expectancy \\<6 months;\n10. Blood glucose \\< 2.8mmol/L (50mg/dl) or \\> 22.2mmol/L (400mg/dl);\n11. Intracranial aneurysm, arteriovenous malformation, or space-occupying brain tumor with mass effect on imaging\n12. Active systemic infectious disease\n13. Anticipated inability to complete follow-up\n14. Intraoperative DSA showed vascular perforation, dissection, and contrast extravasation;\n15. Puncture to recanalization was more than 90 minutes; Total thrombectomy passes \\>3'}, 'identificationModule': {'nctId': 'NCT07141303', 'acronym': 'IMPACT-LVO', 'briefTitle': 'Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Intra-arterial Methylprednisolone After Successful Endovascular Thrombectomy Anterior Circulation Large Vessel Occlusion', 'orgStudyIdInfo': {'id': 'K202508-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The methylprednisolone sodium succinate group', 'description': 'The methylprednisolone sodium succinate group patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.', 'interventionNames': ['Drug: The methylprednisolone sodium succinate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'The placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'The methylprednisolone sodium succinate', 'type': 'DRUG', 'description': 'Patients will receive intra-arterial methylprednisolone sodium succinate 40mg immediately after the recanalization from thrombectomy in anterior circulation large vessel occlusion. Then, intravenous administration with methylprednisolone sodium succinate 2mg/kg in the next 3 days.', 'armGroupLabels': ['The methylprednisolone sodium succinate group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The placebo group patients will receive intra-arterial and intravenous sterile water for injection.', 'armGroupLabels': ['The placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Guo, MD', 'role': 'CONTACT', 'email': '18729985168@163.com', 'phone': '0086-18729985168'}, {'name': 'Yan Qu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Wei Guo, MD', 'role': 'CONTACT', 'email': '18729985168@163.com', 'phone': '0086-18729985168'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Related papers published five years later, the IPD will be shared on ResMan.', 'ipdSharing': 'YES', 'description': 'Related papers published five years later, the IPD will be shared on ResMan.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "The First people's hospital of Xian Yang", 'class': 'UNKNOWN'}, {'name': "First People's Hospital Of Tianshui", 'class': 'UNKNOWN'}, {'name': 'XD Group Hospital', 'class': 'UNKNOWN'}, {'name': "Xi'an Aerospace General Hospital", 'class': 'UNKNOWN'}, {'name': 'First Affiliated Hospital of Chengdu Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}