[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631503":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":26,"collaborators":25,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":25,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":25,"enrollmentInfo":39,"targetDuration":25,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":25,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":25},{"fullName":5,"class":6},"First Affiliated Hospital of Wannan Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Delayed Antihyperglycemic Group","EXPERIMENTAL","Antihyperglycemic treatment is delayed for 72 hours after enrollment. Insulin therapy is initiated on Day 4 targeting blood glucose 7.8-10.0 mmol\u002FL until ICU discharge or Day 14.",[13],"Drug: Intravenous insulin",{"label":15,"type":16,"description":17,"interventionNames":18},"Early Antihyperglycemic Group","ACTIVE_COMPARATOR","Antihyperglycemic treatment is initiated on Day 1. Insulin therapy targets blood glucose 7.8-10.0 mmol\u002FL until ICU discharge or Day 14.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Intravenous insulin","Insulin administered intravenously to maintain blood glucose between 7.8-10.0 mmol\u002FL. Timing of initiation differs by arm: Day 1 for early group, Day 4 for delayed group.",[9,15],null,{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Jie Xu","professor","100631503","phase-2-delayed-versus-early-antihyperglycemic-treatment-for-severe-stroke-100631503",false,"NCT07501533","Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke","Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke: A Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Severe stroke within 24 hours of onset, meeting one of the following criteria:\n\n1）Severe ischemic stroke: Glasgow Coma Scale (GCS) score ≤ 12 or National Institutes of Health Stroke Scale (NIHSS) score ≥ 15 or CT hypodensity \\> 1\u002F3 of middle cerebral artery (MCA) territory; 2）Severe intracerebral hemorrhage: Supratentorial hematoma volume ≥ 30 mL (thalamic hemorrhage ≥ 10 mL) or infratentorial hematoma volume ≥ 10 mL (brainstem hemorrhage ≥ 5 mL); 3）Aneurysmal subarachnoid hemorrhage; 3. Blood glucose level \\> 10 mmol\u002FL at randomization; 4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Known history of type 1 diabetes mellitus;\n2. Known allergy to insulin or diagnosis of insulinoma;\n3. Pre-stroke modified Rankin Scale (mRS) score \\> 1;\n4. Hemodynamic instability refractory to medical treatment (systolic blood pressure \\\u003C 90 mmHg or diastolic blood pressure \\\u003C 60 mmHg);\n5. Decompensated heart failure (New York Heart Association \\[NYHA\\] class III or IV);\n6. Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin;\n7. Expected survival \\\u003C 90 days due to malignancy;\n8. Participation in another drug or device clinical trial within the past 30 days;\n9. Women of childbearing potential who refuse to use effective contraception despite negative pregnancy test, pregnant women, or breastfeeding women.","ALL","18 Years",{"count":40,"type":41},200,"ESTIMATED","INTERVENTIONAL",[44],"PHASE2","This study is a exploratory, randomized, controlled, open-label, blinded-endpoint Phase II clinical trial designed to evaluate whether delaying antihyperglycemic treatment for 72 hours improves neurological outcomes in patients with severe stroke and hyperglycemia.\n\nA total of 426 patients with severe stroke (including ischemic stroke, intracerebral hemorrhage, or aneurysmal subarachnoid hemorrhage) within 24 hours of onset and blood glucose \\>10 mmol\u002FL at randomization will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either delayed antihyperglycemic treatment (initiated on Day 4) or early antihyperglycemic treatment (initiated on Day 1). Glycemic control targets (7.8-10.0 mmol\u002FL) and insulin therapy follow current clinical guidelines.\n\nThe primary outcome is the incidence of poor functional outcome (modified Rankin Scale score ≥ 3) at 90 days. Secondary outcomes include mortality, NIHSS score, GCS score, ICU length of stay, and safety events such as hypoglycemia and infections.\n\nThe study aims to provide evidence on the optimal timing of glycemic control in severe stroke patients with stress hyperglycemia.",[47],"Severe Stroke","NOT_YET_RECRUITING","2026-03-26",{"date":51,"type":52},"2026-03-30","ACTUAL",{"date":54,"type":41},"2026-04-01",{"date":56,"type":41},"2027-11-30",{"name":5,"class":6}]