APEX-STROKE CALM-ICH Domain

Официальное название

Chinese Angong Niuhuang for Acute Medical Management of Intracerebral Hemorrhage (CALM) Domain of the APEX-STROKE Adaptive Platform Trial

Обзор

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. • Intervention: Angong Niuhuang pills (ANP) in addition to guideline-based standard care. ANP 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. • Control condition: matching placebo in addition to guideline-based standard care.

Вмешательства

• Препарат ANP + Standard Care
  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 1
• Препарат Placebo + Standard Care
  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.

Первичные конечные точки

• modified Rankin scale (mRS) scores [Срок оценки: 180 days]

Вторичные конечные точки (5)

• Hematoma volume and hematoma expansion [Срок оценки: 24 hours]
• NIHSS score [Срок оценки: 24 hours and 7 day]
• Mortality [Срок оценки: 180 days]
• Favorable functional outcome (mRS 0-2 and mRS 0-3) [Срок оценки: 180 days]
• Health-Related quality of Life assessed by EQ-5D [Срок оценки: 180 days]

Критерии участия

Критерии включения

• Age ≥ 18 years old;
• Symptom onset or last known well≤ 6 hours before randomization;
• Traditional Chinese Medicine syndrome consistent with heat-toxin internal accumulation: at least two of high fever, flushed face, restlessness, dry mouth, or rapid pulse;
• No surgical plan at the time of randomization;
• All corresponding eligibility criteria must be met according to the randomization setting:

• If randomized in the prehospital (ambulance) setting: AI model predicts ICH, FAST score ≥ 2 and GCS ≥ 8;
• If randomized in the emergency department: brain imaging confirms ICH, hematoma volume ≥ 10 mL, NIHSS score ≥ 8, and GCS score≥ 7;
• Provide written informed consent by patient (or approved surrogate)

Критерии исключения

• Severe comorbid disease likely to interfere with trial treatment, follow-up, or outcome assessment, such as severe heart failure;
• History of epilepsy or seizure-like attack;
• Pregnancy or lactation;
• Subjects meeting any of the following criteria in the corresponding randomization setting shall be excluded:

If randomized in the prehospital (ambulance) setting: blood glucose <2.8 mmol/L; head trauma within the previous 7 days; If randomized in the emergency department: severe hepatic or renal dysfunction, defined as serum creatinine ≥ 2 mg/dL or ALT/AST >3 times the upper limit of normal; secondary cause of hemorrhage, including arteriovenous malformation or other structural abnormality.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07752719 · APEX-STROKE_CALM DOMAIN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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