[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650861":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":27,"collaborators":29,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":11,"enrollmentInfo":50,"targetDuration":11,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":11,"overallStatus":60,"whyStopped":11,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":11},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ANP + Standard Care","ACTIVE_COMPARATOR",null,[13],"Drug: ANP + Standard Care",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo + Standard Care","PLACEBO_COMPARATOR",[18],"Drug: Placebo + Standard Care",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Angong Niuhuang pills (ANP), a Traditional Chinese Medicine formulation supplied as 3 g pills, administered in addition to guideline-based standard care. Awake participants receive one pill orally as soon as possible after randomization. Unconscious participants receive a suspension prepared by removing the pill shell and grinding it with 15 mL room-temperature normal saline (used within 1 hour of preparation): in the ambulance setting, administered onto the tongue in 2-2.5 mL increments every 10 minutes, with the remaining dose given via nasogastric tube after hospital admission; in the emergency department, administered directly via nasogastric tube. After the initial dose, treatment continues as one pill twice daily during week 1 and one pill once daily during week 2, for a total treatment duration of 14 days.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Matching placebo administered in addition to guideline-based standard care, identical to ANP in appearance, smell, taste, dosing schedule, and treatment duration (14 days total). Contains inactive excipients only and is indistinguishable from active treatment to participants, treating teams, outcome assessors, and trial personnel.",[15],{"type":28,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[30,32,34,36,38],{"name":31,"class":6},"Huashan Hospital",{"name":33,"class":6},"Chinese PLA General Hospital",{"name":35,"class":6},"Beijing University of Chinese Medicine",{"name":37,"class":6},"Hubei College of Traditional Chinese Medicine",{"name":39,"class":6},"Guangdong Provincial Hospital of Traditional Chinese Medicine","100650861","phase-3-apex-stroke-calm-ich-domain-100650861",false,"NCT07752719","APEX-STROKE CALM-ICH Domain","Chinese Angong Niuhuang for Acute Medical Management of Intracerebral Hemorrhage (CALM) Domain of the APEX-STROKE Adaptive Platform Trial","CALM-ICH","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Symptom onset or last known well≤ 6 hours before randomization;\n3. Traditional Chinese Medicine syndrome consistent with heat-toxin internal accumulation: at least two of high fever, flushed face, restlessness, dry mouth, or rapid pulse;\n4. No surgical plan at the time of randomization;\n5. All corresponding eligibility criteria must be met according to the randomization setting:\n\n   * If randomized in the prehospital (ambulance) setting: AI model predicts ICH, FAST score ≥ 2 and GCS ≥ 8;\n   * If randomized in the emergency department: brain imaging confirms ICH, hematoma volume ≥ 10 mL, NIHSS score ≥ 8, and GCS score≥ 7;\n6. Provide written informed consent by patient (or approved surrogate)\n\nExclusion Criteria:\n\n1. Severe comorbid disease likely to interfere with trial treatment, follow-up, or outcome assessment, such as severe heart failure;\n2. History of epilepsy or seizure-like attack;\n3. Pregnancy or lactation;\n4. Subjects meeting any of the following criteria in the corresponding randomization setting shall be excluded:\n\nIf randomized in the prehospital (ambulance) setting: blood glucose \\\u003C2.8 mmol\u002FL; head trauma within the previous 7 days; If randomized in the emergency department: severe hepatic or renal dysfunction, defined as serum creatinine ≥ 2 mg\u002FdL or ALT\u002FAST \\>3 times the upper limit of normal; secondary cause of hemorrhage, including arteriovenous malformation or other structural abnormality.","ALL","18 Years",{"count":51,"type":52},1100,"ESTIMATED","INTERVENTIONAL",[55],"PHASE3","In this domain of APEX-STROKE, participants with acute intracerebral hemorrhage (ICH) who are considered suitable for non-surgical management and who meet the eligibility criteria for this domain will be randomized in a 1:1 ratio to receive either Angong Niuhuang pills (ANP) or matching placebo, both in addition to guideline-based standard care. The matching placebo is the control condition and is not counted as a domain intervention.\n\n• Intervention: Angong Niuhuang pills (ANP) in addition to guideline-based standard care.\n\nANP should be initiated as soon as possible after randomization in the ambulance or emergency department setting, with subsequent treatment continued for a total of 14 days according to the domain-specific intervention schedule.\n\n• Control condition: matching placebo in addition to guideline-based standard care.",[58,59],"Stroke","Intracerebral Hemorrhage","NOT_YET_RECRUITING","2026-08-04",{"date":63,"type":64},"2026-08-07","ACTUAL",{"date":66,"type":52},"2026-09-01",{"date":68,"type":52},"2030-02-28",{"name":5,"class":6}]