[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575521":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":44,"centralContacts":54,"locations":62,"responsibleParty":95,"collaborators":32,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":32,"enrollmentInfo":107,"targetDuration":32,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":65,"whyStopped":32,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Shanghai East Hospital","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Levetiracetam","EXPERIMENTAL","Prophylactic use of LEV in the ambulance",[13],"Drug: Levetiracetam",{"label":15,"type":16,"description":15,"interventionNames":17},"Guide-recommended management","ACTIVE_COMPARATOR",[18],"Other: Guide-recommended management",{"label":20,"type":10,"description":20,"interventionNames":21},"Lie flat",[22],"Other: The lying flat (0°) head position",{"label":24,"type":16,"description":24,"interventionNames":25},"Sit up",[26],"Other: The sitting-up (≥30°) head position",[28,33,36,40],{"type":29,"name":9,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Intervention group - to commence IV levetiracetam 500mg as a single bolus in the ambulance, and then to continue as levetiracetam 500mg bid orally after admission to hospital in those with confirmed acute stroke for the next 14 days (at least 7 days if either dead or discharged from hospital if earlier). They will also receive standard management of acute stroke, whether the final diagnosis is ischaemic or ICH",[9],null,{"type":6,"name":15,"description":34,"armGroupLabels":35,"otherNames":32},"To receive stroke management according to standard local guidelines, but to avoid prophylactic use of an anti-seizure drug.",[15],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":32},"The lying flat (0°) head position","Lie flat (0°) - in the ambulance as soon as possible until arrival at hospital.",[20],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":32},"The sitting-up (≥30°) head position","Sit up(30-60°) - in the ambulance as soon as possible until arrival at hospital.",[24],[45,49,52],{"name":46,"affiliation":47,"role":48},"Gang Li, PhD, MD","Tongji University, School of Medicine, Shanghai East Hospital","PRINCIPAL_INVESTIGATOR",{"name":50,"affiliation":51,"role":48},"Craig Anderson, MD, PhD","Fudan University",{"name":53,"affiliation":51,"role":48},"Lili Song, PhD",[55,59],{"name":46,"role":56,"phone":57,"phoneExt":32,"email":58},"CONTACT","86 13621691786","ligang@tongji.edu.cn",{"name":60,"role":56,"phone":32,"phoneExt":32,"email":61},"Chen Chen, PhD, MD","15921119641@163.com",[63,82],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Si County People's Hospital","RECRUITING","Suzhou","Anhui","234399","China","CN",{"type":72,"coordinates":73},"Point",[74,75],116.97889,33.63611,{"lat":75,"lon":74},[78],{"name":79,"role":56,"phone":80,"phoneExt":32,"email":81},"Lei Shi","86 18755733255","275386217@qq.com",{"facility":5,"status":65,"city":83,"state":84,"zip":85,"country":69,"countryCode":70,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Shanghai","Shanghai Municipality","200123",{"type":72,"coordinates":87},[88,89],121.45806,31.22222,{"lat":89,"lon":88},[92],{"name":93,"role":56,"phone":94,"phoneExt":32,"email":61},"Chen Chen, MD PhD","86 15921119641",{"type":96,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100575521","phase-3-early-initiated-ambulance-delivered-levetiracetam-and-headposition-in-hyper-acute-stroke-trial-100575521",false,"NCT06773364","Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial","An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Study of Pre-hospital Initiated Levetiracetam and Headposition in Patients With Presumed Acute Stroke","EAST","Inclusion Criteria:\n\n* Adults (age ≥18 years);\n* Acute condition that is presumed due to acute stroke, defined on the FAST (Face, Arm, Speech, Time) screen (score ≥2 with an arm deficit);\n* Time ≤2 hours from last seen well;\n* Able to provide brief consent (if a waver of consent not approved by ethics committee).\n\nExclusion Criteria:\n\n* coma (no response to painful stimulation);\n* severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia, severe heart failure, pre-existing disability \\[needing help with everyday activities\\]);\n* history of epilepsy or seizure at onset;\n* recent head injury;\n* hypoglycaemia (glucose \\\u003C2.8mmol\u002FL);\n* clear indications or contraindications (allergies) for levetiracetam;\n* lactating women;\n* clear indications for a particular head position or situations where either head position cannot be maintained (such as severe vomiting and inability to lie down, severe obesity with fatigue and difficulty sitting up, etc.).","ALL","18 Years",{"count":108,"type":109},2423,"ESTIMATED","INTERVENTIONAL",[112],"PHASE3","This is an investigator initiated and conducted, multicentre, ambulance-delivered, prospective, randomised, open-label, blinded outcome (PROBE) study. EAST aims to evaluate the effects of pre-hospital levetiracetam and different head positions initiated in ambulance settings on the functional outcome of participants assessed at 90 days.",[115],"Suspected Stroke",[117,118,9,119,120],"Ambulance","Acute stroke","Head position","intervention","2025-05-19",{"date":123,"type":124},"2025-05-22","ACTUAL",{"date":126,"type":124},"2025-04-30",{"date":128,"type":109},"2029-12-31",{"name":5,"class":6},2]