APEX-STROKE CALM-ICH Domain (CALM-ICH)
2026年8月24日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
1100
段階
- フェーズ 3
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
modified Rankin scale (mRS) scores
時間枠：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.
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180 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NIHSS score
時間枠：24 hours and 7 day
|
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
時間枠：180 days
|
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)
時間枠：180 days
|
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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Serious Adverse Events
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2029年1月31日
研究の完了 (推定)
2029年6月30日
試験登録日
最初に提出
2026年7月27日
QC基準を満たした最初の提出物
2026年8月4日
最初の投稿 (実際)
2026年8月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月26日
QC基準を満たした最後の更新が送信されました
2026年8月24日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- APEX-STROKE CALM-ICH DOMAIN
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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