Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-01 @ 6:17 AM
Study NCT ID:
NCT02430350
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2015-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077553', 'term': 'Edaravone'}], 'ancestors': [{'id': 'D000983', 'term': 'Antipyrine'}, {'id': 'D047069', 'term': 'Pyrazolones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-12', 'studyFirstSubmitDate': '2015-04-20', 'studyFirstSubmitQcDate': '2015-04-26', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients with mRS ≤1 on day 90', 'timeFrame': 'day 90'}], 'secondaryOutcomes': [{'measure': 'mRS score on day 90', 'timeFrame': 'day 90'}, {'measure': 'Changes of NIHSS score from baseline on day 14', 'timeFrame': 'day 14'}, {'measure': 'The proportion of patients with NIHSS score 0-1 (including motor function) on day 14, 30, 90', 'timeFrame': 'day 14, 30, 90'}, {'measure': 'The proportion of patients with Barthel Index (BI) score greater than or equal to 95 on day 14, 30, 90', 'timeFrame': 'day 14, 30, 90'}, {'measure': 'Montreal Cognitive Assessment(MoCA) score on day 14, 30, 90', 'timeFrame': 'day 14, 30, 90'}, {'measure': 'Stroke Impact Scale (SIS) score on day 90', 'timeFrame': 'day 90'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '33588596', 'type': 'DERIVED', 'citation': 'Xu J, Wang A, Meng X, Yalkun G, Xu A, Gao Z, Chen H, Ji Y, Xu J, Geng D, Zhu R, Liu B, Dong A, Mu H, Lu Z, Li S, Zheng H, Chen X, Wang Y, Zhao X, Wang Y; TASTE Trial Investigatorsdagger. Edaravone Dexborneol Versus Edaravone Alone for the Treatment of Acute Ischemic Stroke: A Phase III, Randomized, Double-Blind, Comparative Trial. Stroke. 2021 Mar;52(3):772-780. doi: 10.1161/STROKEAHA.120.031197. Epub 2021 Feb 16.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to confirm the efficacy of compound Edaravone Injection via intravenous infusion every 12 hours in the patients with Acute Ischemic Stroke(AIS) in a double-blind, active-controlled manner. The study is also to examine the safety of compound Edaravone Injection for the AIS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients, diagnosed of ischemic stroke;\n* Onset of stroke is less than or equal to 48 hours;\n* There are clear signs of neurological deficit: 4≤NIHSS score≤24, and also, the sum of NIHSS score for the upper limb and the lower limb is greater than or equal to 2;\n* Patients signed written inform consent\n\nExclusion Criteria:\n\n* Cranial CT scan finds intracranial bleeding disorders: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage;\n* Iatrogenic stroke;\n* Severe disturbance of consciousness: NIHSS category 1a for consciousness is greater than 1；\n* The mRS score prior to this onset is greater than 1;\n* Transient ischemic attack (TIA);\n* SBP after blood pressure control is still greater than or equal to 220 mmHg, or DBP after blood pressure control is still greater than or equal to 120 mmHg;\n* Patients with severe mental disorders and dementia;\n* ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis;\n* Serum Creatinine (SCr) is greater than 1.5×ULN, Creatinine Clearance (CrCl) is less than 50 ml/min or previously known severe renal diseases;\n* Therapeutic neuroprotective agents have been applied after onset of stroke, including commercially available edaravone, nimodipine, ganglioside, citicoline, piracetam, butyl benzene peptides, Urinary Kallidinogenase;\n* Arterial or venous thrombolytic therapy has been applied after onset of stroke;\n* Patients with malignant tumors or receiving concurrent antitumor treatment;\n* Patients with severe systemic disease, life expectancy is less than 90 days;\n* allergic to edaravone , (+)-Borneol or related excipients;\n* Pregnant or lactating women;\n* Have major surgery within 4 weeks before enrollment;\n* Participated in other clinical studies within 30 days before randomization; or participating in other clinical trials at present;\n* The investigators consider the patients are not suitable for this trial.'}, 'identificationModule': {'nctId': 'NCT02430350', 'briefTitle': 'Study of Compound Edaravone Injection for Treatment of Acute Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Simcere Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Compound Edaravone Injection for Acute Ischemic Stroke, a Multi-center, Randomized, Double-blind, Parallel, and Active-controlled PhaseⅢTrial', 'orgStudyIdInfo': {'id': 'SIM-23-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Compound Edaravone', 'description': 'Compound Edaravone Injection 37.5mg/dose (Edaravone 30mg, (+)-Borneol 7.5mg), one dose every 12 hours, continue for 14 days', 'interventionNames': ['Drug: Compound Edaravone Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Edaravone', 'description': 'Edaravone Injection 30 mg/dose, one dose every 12 hours, continues for 14 days', 'interventionNames': ['Drug: Edaravone Injection']}], 'interventions': [{'name': 'Compound Edaravone Injection', 'type': 'DRUG', 'armGroupLabels': ['Compound Edaravone']}, {'name': 'Edaravone Injection', 'type': 'DRUG', 'armGroupLabels': ['Edaravone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100048', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Navy General Hospital of The Chinese PLA', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tian Tan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518020', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': "Shenzhen People's Hospital", 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '518036', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Peking 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