[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544882":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":119,"collaborators":27,"id":123,"slug":27,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":124,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":27,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":51,"whyStopped":27,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ICO injection group","EXPERIMENTAL","Y-3 ICO injection (dose was given as 32 ug\u002Fkg) once a day for 3 consecutive days, as well as standard treatment and management according to the related guidelines.",[13,14],"Procedure: Y-3 ICO injection","Other: Conventional treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"intravenous injection group","ACTIVE_COMPARATOR","Y-3 intravenous injection(dose was given as 40mg + 250ml normal saline), as well as standard treatment and management according to related guidelines.",[20,14],"Drug: Y-3 intravenous injection",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Y-3 ICO injection","Patients included will be given skull outer plate drilling surgery and Y-3 ICO injection under local anesthesia and sedation. The injection will be given for 3 consecutive days.",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DRUG","Y-3 intravenous injection","Patients included will be given Y-3 intravenous injection for 7 consecutive days.",[16],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Conventional treatment","standard treatment and management according to related guidelines during the entire treatment period",[9,16],[38],{"name":39,"affiliation":40,"role":41},"Yilong Wang, PhD，MD","Beijing Tiantan Hospital, Capital Medical University, Beijing, China","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":27,"email":47},"Yilong Wang, PhD+MD","CONTACT","18842627325\u002F13261655100","yilong528@gmail.com",[49,66,78,90,96,108],{"facility":50,"status":51,"city":52,"state":53,"zip":27,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"The first affiliated hospital of Wannan Medical College","RECRUITING","Wuhu","Anhui","China",{"type":56,"coordinates":57},"Point",[58,59],118.42947,31.35259,{"lat":59,"lon":58},[62,64],{"name":63,"role":45,"phone":27,"phoneExt":27,"email":27},"Shoucai Zhao, MD",{"name":65,"role":45,"phone":27,"phoneExt":27,"email":27},"Zhenbao Li, MD",{"facility":5,"status":51,"city":67,"state":68,"zip":69,"country":54,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Beijing","Beijing Municipality","100050",{"type":56,"coordinates":71},[72,73],116.39723,39.9075,{"lat":73,"lon":72},[76],{"name":39,"role":45,"phone":27,"phoneExt":27,"email":77},"yilong538@gmail.com",{"facility":79,"status":51,"city":80,"state":81,"zip":27,"country":54,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"North China University of Science and Technology Affiliated Hospital","Tangshan","Heibei",{"type":56,"coordinates":83},[84,85],118.18319,39.64381,{"lat":85,"lon":84},[88],{"name":89,"role":45,"phone":27,"phoneExt":27,"email":27},"Yachen An, MD",{"facility":91,"status":92,"city":80,"state":81,"zip":27,"country":54,"cosmosGeoPoint":93,"geoPoint":95,"contacts":27},"Tangshan Municipal Worker's Hospital","WITHDRAWN",{"type":56,"coordinates":94},[84,85],{"lat":85,"lon":84},{"facility":97,"status":51,"city":98,"state":99,"zip":27,"country":54,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Shaanxi Provincial People's Hospital","Xi'an","Shaanxi",{"type":56,"coordinates":101},[102,103],108.92861,34.25833,{"lat":103,"lon":102},[106],{"name":107,"role":45,"phone":27,"phoneExt":27,"email":27},"Wei Hu, MD",{"facility":109,"status":51,"city":110,"state":27,"zip":27,"country":54,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Tianjin Huanhu hospital","Tianjin",{"type":56,"coordinates":112},[113,114],117.17667,39.14222,{"lat":114,"lon":113},[117],{"name":118,"role":45,"phone":27,"phoneExt":27,"email":27},"Jialing Wu, MD",{"type":120,"investigatorFullName":121,"investigatorTitle":122,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","yilong Wang","Vice President of Beijing Tiantan Hospital","100544882",false,"NCT06374667","The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction","The Efficacy and Safety of Y-3 Intracalvariosseous Injection Bypassing Blood-brain Barrier Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction（SOLUTION-2）","SOLUTION-2","Inclusion Criteria:\n\n* 18≤Age≤80 years;\n* First stroke or complete self-care before the onset of current stroke (mRS 0-1);\n* Administration of drugs can be completed within 24h of the onset of signs and symptoms of neurological deficits (in patients with wake-up strokes or unwitnessed strokes, the time of onset is defined as the time of last normal presentation);\n* Clinical symptoms, signs and imaging diagnosis of cerebral infarction in the area supplied by the middle cerebral artery, together with the following features:\n\n  1. 16≤ NIHSS ≤32 points, and the sum of the scores of motor arm and motor leg is ≥6;\n  2. Imaging suggestive of core infarct area: apparent diffusion coefficient (ADC) values \\\u003C620×10\\^-6mm\\^2\u002Fs lesion volume on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequences or cerebral blood flow (CBF) \\\u003C30% of volume 70-300 ml on computed tomography perfusion imaging (CTP) or an Alberta Stroke Program Early CT Score (ASPECTS) of 0-6, with inconsistent findings, the investigator is required to make a reasoned judgement by taking into account all the information (scanning time, the imaging method that best responds to the size of infarct, etc.) and record it.\n* NIHSS score not improving or progressing after reperfusion therapy and total score still ≤32.\n* Informed consent signed\n\nExclusion Criteria:\n\n* Complications with other cerebrovascular diseases meet one of the following conditions:\n\n  1. Complicated with acute cerebral hemorrhage and subarachnoid hemorrhage;\n  2. Complicated with acute posterior circulation cerebral infarction or severe posterior circulation stenosis (\\>70%);\n  3. Or imaging suggests that the area of cerebral infarction is involved bilaterally;\n  4. The cause of the TOAST classification was considered as intracranial artery dissection, vasculitis, moyamoya disease and other etiological types.\n* Hemorrhage transformation in the infarction area, hematoma area ≥30% of the infarction area, and has obvious space-occupying effect;\n* Presence of clinical signs of brain herniation formation, e.g., unilateral or bilateral pupil dilation and fixation; cerebral oedema-associated loss of consciousness (NIHSS 1a \\> 2 points), or other loss of brainstem reflexes in the judgement of the investigator, caused by cerebral oedema or cerebral herniation formation; or other signs of instability of vital signs that are difficult to control;\n* Craniotomy decompression was planned before randomization;\n* Refractory hypertension (systolic \\> 200mmHg or diastolic \\> 110mmHg) or hypotension (systolic \\\u003C 70mmHg or diastolic \\\u003C 50mmHg) that is difficult to control with medication;\n* Abnormal blood glucose before randomization (random venous blood glucose \\\u003C 2.8mmol\u002FL or \\> 23mmol\u002FL);\n* Presence of significant abnormal liver function markers or renal function markers prior to randomization;\n* Note: Severe liver function abnormalities were defined as serum alanine aminotransferase (ALT), or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN). Significant renal insufficiency is defined as eGFR less than 60 mL\u002Fmin\u002F1.73 m² (eGFR, calculated using the CKD-EPI formula)\n* Acute ST-elevation myocardial infarction (MI) and\u002For decompensated heart failure (meeting the New York College of Cardiology (NYHA) Heart function grades III and IV) within the past 3 months;\n* Presence of contraindications to intracalvariosseous injection, e.g., skull fracture in the last 3 months, skull infection, subdural\u002Fextradural hematoma, subcutaneous hematoma, skin or subcutaneous infection of the scalp, poorly displayed skull bone marrow niches；\n* Bleeding tendencies considered by the investigators to be detrimental to the procedure include, but are not limited to, platelet counts \\\u003C 100×10\\^9\u002FL, and the presence of clotting disorders such as hemophilia；\n* Presence of severe or very severe anemia (hemoglobin \\\u003C60 g\u002FL) at randomization；\n* Patients with severe respiratory diseases (severe chronic obstructive pulmonary disease, respiratory failure, etc.) should be corrected by intubation, tracheotomy, or ventilator;\n* The subjects were considered to have developed clinically significant serious infections, including severe local infections or systemic infections;\n* Diagnosed severe degenerative diseases of the central nervous system such as Alzheimer's Disease (AD), Parkinson's Disease (PD), and severe dementia of all causes, or psychiatric disorders (e.g., schizophrenia, depression, etc.);\n* Subjects with a life expectancy of less than 3 months due to conditions not considered current by the investigators, such as tumors;\n* Known allergy to any component of investigational process therapy drugs and contrast agents;\n* Subjects who are pregnant, breastfeeding or have the possibility of becoming pregnant or plan to become pregnant;\n* Subjects are unable to comply with trial protocols or follow-up requirements;\n* Other circumstances deemed by the investigators to be unsuitable for enrollment (registration of reasons for inability to enroll is required);\n* Have participated in other interventional clinical trials.","ALL","18 Years","80 Years",{"count":134,"type":135},134,"ESTIMATED","INTERVENTIONAL",[138],"NA","A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.",[141,142],"Stroke, Acute Ischemic","Blood-Brain Barrier",[144,145,146,147,148,149],"large hemispheric infarction","Y-3","postsynaptic density protein 95 inhibitor","BBB-bypassing route","brain drug delivery","intracalvariosseous injection","2025-01-24",{"date":152,"type":153},"2025-01-28","ACTUAL",{"date":155,"type":153},"2024-04-22",{"date":157,"type":135},"2027-03-15",{"name":121,"class":6},6]