APEX-STROKE CALM-ICH Domain (CALM-ICH)
2026년 8월 24일 업데이트: Fudan University
Chinese Angong Niuhuang for Acute Medical Management of Intracerebral Hemorrhage (CALM-ICH) Domain of the APEX-STROKE Adaptive Platform Trial
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.
연구 개요
연구 유형
중재적
등록 (추정된)
1100
단계
- 3단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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설명
Inclusion Criteria
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 ≥8.
- Glasgow Coma Scale (GCS) score ≥8.
- 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 ≥2.
- 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.
Exclusion Criteria
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Early Angong Niuhuang Pill (ANP) treatment
Participants in this arm receive early treatment with ANP Within 6 hours of onset.
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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.
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위약 비교기: Placebo
Participants in this arm will not receive ANP and will receive a matching placebo.
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Matching placebo, identical to Angong Niuhuang pills (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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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modified Rankin scale (mRS) scores
기간: 180 days
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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.
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180 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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NIHSS score
기간: 24 hours and 7 day
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The National Institutes of Health Stroke Scale (NIHSS) ranges from 0 (no neurological deficit) to 42 (most severe deficit), assessing consciousness, gaze, visual fields, motor and sensory function, language, and neglect.
Higher scores indicate more severe neurological impairment.
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24 hours and 7 day
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Mortality
기간: 180 days
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All-cause mortality will be reported as the number and proportion of participants who died from any cause by 180 days after randomization.
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180 days
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Favorable functional outcome (mRS 0-2 and mRS 0-3)
기간: 180 days
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Favorable functional outcome is defined using the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death).
Two thresholds will be reported: participants achieving mRS 0-2 (no symptoms to slight disability, independent living) and participants achieving mRS 0-3 (no symptoms to moderate disability, ambulatory without assistance).
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180 days
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Health-Related quality of Life assessed by EQ-5D
기간: 180 days
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The EQ-5D assesses health-related quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each scored on a severity scale, combined into a weighted index value, with an accompanying EQ visual analogue scale (EQ-VAS) rated from 0 (worst imaginable health) to 100 (best imaginable health).
Higher scores indicate better health status.
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180 days
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Hematoma volume
기간: 24 hours
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Hematoma volume will be measured on brain CT/MRI in mL using semi-automated volumetric software.
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24 hours
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Hematoma Expansion at 24 Hours
기간: 24 hours
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Hematoma expansion is defined as an absolute increase of ≥6 mL or a relative increase of ≥33% in hematoma volume between baseline and the 24-hour scan.
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24 hours
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Serious Adverse Events
기간: From randomization through 180 days after randomization
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Incidence of serious adverse events (SAEs) occurring during the safety follow-up period.
An SAE is defined as an adverse event resulting in death, a life-threatening event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that, based on appropriate medical judgment, may jeopardize the participant or require medical or surgical intervention to prevent one of these outcomes.
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From randomization through 180 days after randomization
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Incidence of Adverse Events of Special Interest
기간: From randomization through 180 days after randomization
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Incidence of adverse events of special interest (AESIs) during the safety follow-up period.
AESIs include whole-blood mercury or arsenic concentrations ≥2 times the upper limit of normal (ULN), liver function abnormalities defined as alanine aminotransferase or aspartate aminotransferase >3 times the ULN, and renal function abnormalities defined as serum creatinine ≥2 mg/dL.
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From randomization through 180 days after randomization
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2029년 1월 31일
연구 완료 (추정된)
2029년 6월 30일
연구 등록 날짜
최초 제출
2026년 7월 27일
QC 기준을 충족하는 최초 제출
2026년 8월 4일
처음 게시됨 (실제)
2026년 8월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 24일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- APEX-STROKE CALM-ICH DOMAIN
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
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