Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-01-04 @ 9:18 AM
Study NCT ID:
NCT04817527
Status:
UNKNOWN
Last Update Posted:
2022-04-01
First Post:
2021-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2021-03-25', 'studyFirstSubmitQcDate': '2021-03-25', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with modified Rankin Score 0 to 3 on day 90', 'timeFrame': '90 days'}, {'measure': 'Proportion of symptomatic intracranial hemorrhage (sICH)', 'timeFrame': '48 hours'}, {'measure': 'mTICI grade (<2 b、≥2 b) stratified for primary outcome analysis', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Changes in National Institute of Health stroke scale (NIHSS) on day 2,7,14', 'timeFrame': '14 days'}, {'measure': 'Distribution of modified Rankin Score after the treatment', 'timeFrame': '90 days'}, {'measure': 'Change in infarct volume', 'timeFrame': '7 days'}, {'measure': 'The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90', 'timeFrame': '90 days'}, {'measure': 'Activity of Daily Living Scale(ADL) score on day 14, 30, 90', 'timeFrame': '90 days'}, {'measure': 'Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90', 'timeFrame': '90 days'}, {'measure': 'Serum inflammatory factors changes on day 1 and day 7', 'timeFrame': '7 days'}, {'measure': 'Proportion of PH1 and PH2 within 48 hours after the treatment', 'timeFrame': '48 hours'}, {'measure': 'Midline shift on the CT scan', 'timeFrame': '7 days'}, {'measure': 'Proportion of death due to any cause', 'timeFrame': '90 days'}, {'measure': 'Proportion of Serious adverse events(SAE)', 'timeFrame': '90 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endovascular therapy', 'Extended Time Windows'], 'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'To explore the safety and efficacy of edaravone dexborneol for patients of acute ischemic stroke received endovascular therapy in extended time windows.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 to 80 years of age;\n2. Acute ischemic stroke with National Institute of Health Stroke Scale (NIHSS) ≥ 10 and Volume of infarction on DWI \\<31ml or with a NIHSS ≥20 and 31ml\\<Volume of infarction\\<51ml(DWI);\n3. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation;\n4. Endovascular Therapy in 6-24 hours of stroke onset;\n5. The availability of informed consent.\n\nExclusion Criteria:\n\n1. First ever stroke or mRS≤1 after previous disease;\n2. Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;\n3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia\n4. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;\n5. Severe cardiac or pulmonary disease;\n6. Patients with malignant tumor or under antineoplastic therapy with estimated lifetime less than 3 months;\n7. Pregnancy, plan to get pregnant or during lactation;\n8. Patients with contraindication or allergic to any ingredient of drugs in our study;\n9. Unsuitable for this clinical studies assessed by researcher'}, 'identificationModule': {'nctId': 'NCT04817527', 'acronym': 'EXISTENT', 'briefTitle': 'Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'Edaravone Dexborneol for Treatment of Acute Ischemic Stroke With Endovascular Therapy in Extended Time Windows (EXISTENT):a Prospective, Randomized, Open-label, Multi-centre Study', 'orgStudyIdInfo': {'id': 'XJTU1AF2021LSK-065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Edaravone Dexborneol', 'interventionNames': ['Drug: Edaravone Dexborneol']}, {'type': 'NO_INTERVENTION', 'label': 'conventional therapy', 'description': 'conventional therapy of acute ischemic stroke after Endovascular Therapy based on Chinese guidelines for endovascular therapy'}], 'interventions': [{'name': 'Edaravone Dexborneol', 'type': 'DRUG', 'description': 'Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.', 'armGroupLabels': ['Edaravone Dexborneol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianfeng Han, MD', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital of Xian Jiaotong University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Jianfeng Han, MD', 'role': 'CONTACT', 'email': 'rabbit1110@163.com', 'phone': '+8618991232708'}, {'name': 'Ying Tan, MD', 'role': 'CONTACT', 'email': '13581693768@163.com', 'phone': '+8613581693768'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}