Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:41 PM
Study NCT ID:
NCT07260760
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Comprehensive Evaluation of Neuroprotective Drugs for 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with Modified Rankin Scale（mRS ）scores of 0-1', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with mRS scores of 0-2', 'timeFrame': '30 days'}, {'measure': 'Percentage reduction in National Institutes of Health Stroke Scale （NIHSS ）score compared to pre-treatment', 'timeFrame': '90 days after medication'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute ischemic stroke', 'Neuroprotective drugs', 'Real-world studies'], 'conditions': ['Acute Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '38372981', 'type': 'RESULT', 'citation': 'Fu Y, Wang A, Tang R, Li S, Tian X, Xia X, Ren J, Yang S, Chen R, Zhu S, Feng X, Yao J, Wei Y, Dong X, Ling Y, Yi F, Deng Q, Guo C, Sui Y, Han S, Wen G, Li C, Dong A, Sun X, Wang Z, Shi X, Liu B, Fan D. Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial. JAMA Neurol. 2024 Feb 19;81(4):319-26. doi: 10.1001/jamaneurol.2023.5716. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This study conducted a comprehensive evaluation of commonly used neuroprotective agents in acute ischemic stroke, assessing their real-world value across six dimensions: safety, efficacy, cost-effectiveness, innovativeness, appropriateness, and accessibility. Employing a prospective observational design, it primarily investigates the association of edaravone and dexrazoxane with clinical outcomes in patients with mild-to-moderate stroke, with subgroup analyses performed according to Trial of Org 10172 in Acute Stroke Treatment （TOAST ）classification.', 'detailedDescription': 'A comprehensive evaluation of commonly used clinical neuroprotective drugs was conducted, analyzing their practical application value in acute ischemic stroke treatment across six dimensions: safety, efficacy, cost-effectiveness, innovation, appropriateness, and accessibility. In a real-world clinical setting, this prospective observational study design primarily evaluates the association between edaravone and dexrazoxane usage and the efficacy and safety outcomes in patients with mild-to-moderate ischemic stroke, while conducting subgroup analyses based on different Trial of Org 10172 in Acute Stroke Treatment （TOAST ）classifications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ischemic stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1: Age≥18\n\n 2: Acute ischemic stroke in the anterior circulation occurring within 48 hours\n\n 3: Baseline NIHSS score of 1-15 points (mild stroke: baseline NIHSS score of 1-5 points; moderate stroke: baseline NIHSS score of 6-15 points)\n\n 4: Pre-onset mRS score≤1\n\n 5: Use of Edaravone (injection or tablets)\n\n 6: Exclude intracranial hemorrhage\n\n 7: Sign the informed consent form\n\nExclusion Criteria:\n\n* 1: A head CT or MRI scan indicates the presence of intracranial hemorrhagic disease\n\n 2: Patients with cerebral embolism or suspected cerebral embolism who also have severe atrioventricular block, atrial fibrillation, myocardial infarction, valvular heart disease, infective endocarditis, or a heart rate below 50 beats per minute\n\n 3: Abnormal liver function (ALT or AST transaminase levels exceeding the upper limit of normal), abnormal kidney function (creatinine levels exceeding the upper limit of normal), or individuals with other severe systemic diseases, etc\n\n 4: Allergy to the test drug'}, 'identificationModule': {'nctId': 'NCT07260760', 'acronym': 'Ischemic strok', 'briefTitle': 'Clinical Comprehensive Evaluation of Neuroprotective Drugs for Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Clinical Comprehensive Evaluation of Neuroprotective Drugs for Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'YXLL-KY-2025(206)'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yan Li', 'role': 'CONTACT', 'email': 'li_xyan@126.com', 'phone': '13791126823'}], 'overallOfficials': [{'name': 'Xiaofang Niu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heze Municipal Hospital'}, {'name': 'Leqing Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Yanggu County People's Hospital"}, {'name': 'Lei Duan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zibo Central Hospital'}, {'name': 'Kai Ren', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Haiyang People's Hospital"}, {'name': 'Rongrong Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Sishui County People's Hospital"}, {'name': 'Ping Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Jinan Fourth People's Hospital"}, {'name': 'Ning Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Hospital of Integrated Traditional Chinese and Western Medicine'}, {'name': 'Pengcheng Du', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University, Dezhou Branch'}, {'name': 'Hui Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Jinan Municipal People's Hospital"}, {'name': 'Xi Rong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weifang Yidu Central Hospital'}, {'name': 'Deyin Zhai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linyi Traditional Chinese Medicine Hospital'}, {'name': 'Zhiqiang Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Anqiu People's Hospital"}, {'name': 'Jiyong Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shandong Provincial Second People's Hospital"}, {'name': 'Meixia Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jining Medical University Affiliated Hospital'}, {'name': 'Ping Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Liaocheng People's Hospital"}, {'name': 'Jiyao Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Liaocheng Municipal People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Pharmacist', 'investigatorFullName': 'LI YAN', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}