Chinese Angong Niuhuang for Acute Medical Management of Intracerebral Hemorrhage (CALM-ICH) Domain of the APEX-STROKE Adaptive Platform Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,100
- 主要终点
- modified Rankin scale (mRS) scores
研究概览
简要总结
In this domain of APEX-STROKE, participants with acute intracerebral hemorrhage (ICH) 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-Hospital Setting
- •Age ≥18 years.
- •Symptom onset or last known well ≤6 hours before randomization. Intracerebral hemorrhage (ICH) confirmed by brain imaging, with a hematoma volume ≥10 mL.
- •National Institutes of Health Stroke Scale (NIHSS) score ≥
- •Glasgow Coma Scale (GCS) score ≥
- •Traditional Chinese medicine (TCM) syndrome consistent with internal accumulation of heat-toxin, defined by the presence of at least 2 of the following: high fever, facial flushing, agitation, dry mouth, and rapid pulse.
- •No surgery performed at the time of randomization.
- •Written informed consent obtained from the participant or their legally authorized representative.
- •Prehospital (Ambulance) Setting
- •Age ≥18 years.
- •Symptom onset or last known well ≤6 hours before randomization.
- •Predicted to have ICH by an artificial intelligence-based model.
- •FAST score ≥
- •TCM syndrome consistent with internal accumulation of heat-toxin, defined by the presence of at least 2 of the following: high fever, facial flushing, agitation, dry mouth, and rapid pulse.
- •Written informed consent obtained from the participant or their legally authorized representative.
排除标准
- •In-Hospital Setting
- •Secondary ICH, including ICH associated with cerebrovascular malformations or other structural abnormalities, brain tumors, head trauma, hemorrhagic transformation of cerebral infarction, or bleeding following thrombolysis or thrombectomy.
- •Severe comorbidities that may interfere with study treatment, follow-up, or outcome assessment (e.g., severe heart failure, malignant tumors, chronic obstructive pulmonary disease, or severe pre-existing disability).
- •Known allergy to Angong Niuhuang Wan or any of its ingredients.
- •Pregnancy or breastfeeding.
- •History of severe chronic kidney disease or hepatic failure.
- •Very high likelihood of death within 7 days or poor anticipated adherence to study treatment or follow-up.
- •Prehospital (Ambulance) Setting
- •Blood glucose <2.8 mmol/L.
- •History of head trauma within the previous 7 days.
- •History of seizures or seizure-like episodes.
- •Severe comorbidities that may interfere with study treatment, follow-up, or outcome assessment (e.g., severe heart failure, malignant tumors, chronic obstructive pulmonary disease, or severe pre-existing disability).
- •Known allergy to Angong Niuhuang Wan or any of its ingredients.
- •Pregnancy or breastfeeding.
- •History of severe chronic kidney disease or hepatic failure.
- •Very high likelihood of death within 7 days or poor anticipated adherence to study treatment or follow-up.
研究组 & 干预措施
ANP + Standard Care
干预措施: ANP + Standard Care (Drug)
Placebo + Standard Care
干预措施: Placebo + Standard Care (Drug)
结局指标
主要结局
modified Rankin scale (mRS) scores
时间窗: 180 days
The modified Rankin Scale (mRS) is a 7-point ordinal scale assessing global disability and functional dependence after stroke, ranging from 0 (no symptoms) to 6 (death). Intermediate scores indicate increasing severity: 1, no significant disability; 2, slight disability; 3, moderate disability; 4, moderately severe disability; 5, severe disability. The primary analysis will use the ordinal distribution of scores across all 7 levels; lower scores indicate better functional outcome.
次要结局
- Hematoma volume and hematoma expansion(24 hours)
- NIHSS score(24 hours and 7 day)
- Mortality(180 days)
- Favorable functional outcome (mRS 0-2 and mRS 0-3)(180 days)
- Health-Related quality of Life assessed by EQ-5D(180 days)
- Hematoma volume(24 hours)
- Hematoma Expansion at 24 Hours(24 hours)