[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582293":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":40,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":197,"collaborators":20,"id":201,"slug":20,"hasResults":202,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":202,"sex":208,"minAge":209,"maxAge":20,"enrollmentInfo":210,"targetDuration":20,"studyType":213,"phases":20,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":221,"whyStopped":20,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},{"fullName":5,"class":6},"Dongzhimen Hospital, Beijing","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients with an mRS score of 0 or 1","Modified Rankin Scale (mRS) is a 6-point ordinal scale from 0 \\[no symptoms\\] to 5 \\[severe disability\\] when excluding mortality, with lower scores indicating better functional outcome)","on day 90 after onset",[14,16,18,22,24],{"measure":15,"description":11,"timeFrame":12},"Proportion of patients with an mRS score of 2 or less",{"measure":17,"description":11,"timeFrame":12},"Distribution of mRS scores",{"measure":19,"description":20,"timeFrame":21},"Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke)",null,"within 90 days after onset",{"measure":23,"description":20,"timeFrame":21},"Mortality rate",{"measure":25,"description":20,"timeFrame":26},"Incidence of severe or moderate bleeding events (as defined by GUSTO criteria)","during hospital stay (up to 14 days)",{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":28,"timePerspective":6,"maskingInfo":20},"COHORT","The randomized controlled trial (RCT) of GDLM for the treatment of AIS was published in JAMA Network Open, titled \"Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial.\" This study provided valuable insights into the efficacy and safety of GDLM in improving functional recovery for patients with AIS. However, the generalizability of these findings to real-world medical settings remains unclear, as the trial was conducted under controlled conditions that may not fully reflect routine clinical practice. To address this gap, we will conduct this study to further explore the effectiveness of GDLM in a real medical environment. Using routine clinical care data for real-world evidence, we aim to investigate the treatment's impact on a broader and more diverse patient population. This approach will allow us to better understand the practical application of GDLM in everyday clinical settings, including its potential benefits and challenges when used outside the confines of a RCT.","AIS patients within 48 hours of symptom onset from certified stroke centers across China",[32,37],{"label":33,"type":20,"description":34,"interventionNames":35},"GDLM group","AIS patients received GDLM and guideline-standardized treatment within 48 hours of symptom onset",[36],"Drug: Ginkgo Diterpene Lactone Meglumine",{"label":38,"type":20,"description":39,"interventionNames":20},"Non-exposed Group","AIS patients initiated guideline-standardized treatment within 48 hours of symptom onset without exposure to Ginkgo-derived preparations.",[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","Ginkgo Diterpene Lactone Meglumine","The specific administration protocol (including time of initiation, dosage, and treatment duration) should be strictly adhered to as per the physician's prescription and meticulously documented in the case report forms (CRFs).",[33],[47,48],"Ginkgo Diterpene Lactone Meglumine Injection","Diterpene Ginkgolides Meglumine Injection",[50],{"name":51,"affiliation":5,"role":52},"Ying Gao, PHD","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":20,"email":58},"Sijin Wang, PHD","CONTACT","+86-17812051019","20230941128@bucm.edu.cn",[60,78,93,103,118,133,143,157,172,187],{"facility":61,"status":20,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Gansu Provincial People's Hospital","Lanzhou","Gansu","730000","China","CN",{"type":68,"coordinates":69},"Point",[70,71],103.83987,36.05701,{"lat":71,"lon":70},[74],{"name":75,"role":56,"phone":76,"phoneExt":20,"email":77},"Yamin Zhang","+86-13619346412","yamin309@163.com",{"facility":79,"status":20,"city":80,"state":81,"zip":82,"country":65,"countryCode":66,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Harbin Second Hospital","Harbin","Heilongjiang","150000",{"type":68,"coordinates":84},[85,86],126.65,45.75,{"lat":86,"lon":85},[89],{"name":90,"role":56,"phone":91,"phoneExt":20,"email":92},"Youwen Hou","+86-18645001271","hou0422@163.com",{"facility":94,"status":20,"city":80,"state":81,"zip":82,"country":65,"countryCode":66,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"The Fourth Affiliated Hospital of Harbin Medical University",{"type":68,"coordinates":96},[85,86],{"lat":86,"lon":85},[99],{"name":100,"role":56,"phone":101,"phoneExt":20,"email":102},"Xueling Ma","+86-15046668187","marlenexl@163.com",{"facility":104,"status":20,"city":105,"state":106,"zip":107,"country":65,"countryCode":66,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Henan Provincial People's Hospital","Zhengzhou","Henan","450000",{"type":68,"coordinates":109},[110,111],113.64861,34.75778,{"lat":111,"lon":110},[114],{"name":115,"role":56,"phone":116,"phoneExt":20,"email":117},"Chao Jiang","+86-13783538665","chaojzzu@126.com",{"facility":119,"status":20,"city":120,"state":121,"zip":122,"country":65,"countryCode":66,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Jiangsu Geriatric Hospital","Nanjing","Jiangsu","210000",{"type":68,"coordinates":124},[125,126],118.77778,32.06167,{"lat":126,"lon":125},[129],{"name":130,"role":56,"phone":131,"phoneExt":20,"email":132},"Huifen Zheng","+86-13357818755","zhenghuifen@163.com",{"facility":134,"status":20,"city":120,"state":121,"zip":122,"country":65,"countryCode":66,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"Jiangsu Provincial Hospital of Traditional Chinese Medicine",{"type":68,"coordinates":136},[125,126],{"lat":126,"lon":125},[139],{"name":140,"role":56,"phone":141,"phoneExt":20,"email":142},"Minghua Wu","+86-13951786719","mhuawu@163.com",{"facility":144,"status":20,"city":145,"state":121,"zip":146,"country":65,"countryCode":66,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Xuzhou Hospital of Traditional Chinese Medicine","Xuzhou","221000",{"type":68,"coordinates":148},[149,150],117.28386,34.20442,{"lat":150,"lon":149},[153],{"name":154,"role":56,"phone":155,"phoneExt":20,"email":156},"Jiangfeng Shi","+86-15952260819","2206777257@qq.com",{"facility":158,"status":20,"city":159,"state":160,"zip":161,"country":65,"countryCode":66,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"The First Hospital of Jilin University","Changchun","Jilin","130000",{"type":68,"coordinates":163},[164,165],125.32278,43.88,{"lat":165,"lon":164},[168],{"name":169,"role":56,"phone":170,"phoneExt":20,"email":171},"Xin Sun","+86-13596116866","sjnksunxin@163.com",{"facility":173,"status":20,"city":174,"state":175,"zip":176,"country":65,"countryCode":66,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Affiliated Hospital of Jining Medical University","Jining","Shandong","272000",{"type":68,"coordinates":178},[179,180],116.58139,35.405,{"lat":180,"lon":179},[183],{"name":184,"role":56,"phone":185,"phoneExt":20,"email":186},"Daojing Li","+86-18553770506","lidaojing0415@163.com",{"facility":188,"status":20,"city":189,"state":190,"zip":191,"country":65,"countryCode":66,"cosmosGeoPoint":20,"geoPoint":20,"contacts":192},"Xian Changan District Hospital","Xian","Shanxi","710000",[193],{"name":194,"role":56,"phone":195,"phoneExt":20,"email":196},"Xianjun Hao","+86-13488116665","1581270512@qq.com",{"type":198,"investigatorFullName":199,"investigatorTitle":200,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Ying Gao","Professor","100582293",false,"NCT06861426","Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke","Patients with Acute Ischemic Stroke Receiving Ginkgo Diterpene Lactone Meglumine: a Patient Registry","PIONEER","Inclusion Criteria:\n\n* aged ≥18 years, regardless of gender\n* within 48 hours of stroke onset of ischemic stroke\n* patient or their legally authorized representative (LAR) has signed informed consent or legally authorized oral consent with documentation\n\nExclusion Criteria:\n\n* mRS score of 2 or more prior to onset\n* total hospital stay less than 7 days\n* use of other ginkgo-derived preparations except GDLM\n* current or planned participation in any other interventional clinical trials\n* inability to comply with study procedures due to documented psychiatric disorders or severe cognitive impairment","ALL","18 Years",{"count":211,"type":212},4460,"ESTIMATED","OBSERVATIONAL","The primary purpose of this study is to investigate the effectiveness of Ginkgo Diterpene Lactone Meglumine (GDLM) for patients with acute ischemic stroke (AIS) in real-world settings.",[216],"Acute Ischemic Stroke",[43,216,218,219,220],"Real-World Study","Registry","Effectiveness","NOT_YET_RECRUITING","2025-03-04",{"date":224,"type":225},"2025-03-06","ACTUAL",{"date":227,"type":212},"2025-03-01",{"date":229,"type":212},"2025-12-31",{"name":199,"class":6},10]