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APEX-STROKE CALM-ICH Domain (CALM-ICH)

24 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1100

Fase

  • Fase 3

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria

  • In-Hospital Setting

    1. Age ≥18 years.
    2. Symptom onset or last known well ≤6 hours before randomization. Intracerebral hemorrhage (ICH) confirmed by brain imaging, with a hematoma volume ≥10 mL.
    3. National Institutes of Health Stroke Scale (NIHSS) score ≥8.
    4. Glasgow Coma Scale (GCS) score ≥8.
    5. 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.
    6. No surgery performed at the time of randomization.
    7. Written informed consent obtained from the participant or their legally authorized representative.

  • Prehospital (Ambulance) Setting

    1. Age ≥18 years.
    2. Symptom onset or last known well ≤6 hours before randomization.
    3. Predicted to have ICH by an artificial intelligence-based model.
    4. FAST score ≥2.
    5. 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.
    6. Written informed consent obtained from the participant or their legally authorized representative.

Exclusion Criteria

  • In-Hospital Setting

    1. 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.
    2. 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).
    3. Known allergy to Angong Niuhuang Wan or any of its ingredients.
    4. Pregnancy or breastfeeding.
    5. History of severe chronic kidney disease or hepatic failure.
    6. Very high likelihood of death within 7 days or poor anticipated adherence to study treatment or follow-up.

  • Prehospital (Ambulance) Setting

    1. Blood glucose <2.8 mmol/L.
    2. History of head trauma within the previous 7 days.
    3. History of seizures or seizure-like episodes.
    4. 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).
    5. Known allergy to Angong Niuhuang Wan or any of its ingredients.
    6. Pregnancy or breastfeeding.
    7. History of severe chronic kidney disease or hepatic failure.
    8. Very high likelihood of death within 7 days or poor anticipated adherence to study treatment or follow-up.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Early Angong Niuhuang Pill (ANP) treatment
Participants in this arm receive early treatment with ANP Within 6 hours of onset.
Droga: Angong Niuhuang Pills (ANP)
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.
Comparador de placebos: Placebo
Participants in this arm will not receive ANP and will receive a matching placebo.
Droga: Placebo
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
modified Rankin scale (mRS) scores
Periodo de tiempo: 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.
180 days

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
NIHSS score
Periodo de tiempo: 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.
24 hours and 7 day
Mortality
Periodo de tiempo: 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.
180 days
Favorable functional outcome (mRS 0-2 and mRS 0-3)
Periodo de tiempo: 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).
180 days
Health-Related quality of Life assessed by EQ-5D
Periodo de tiempo: 180 days
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.
180 days
Hematoma volume
Periodo de tiempo: 24 hours
Hematoma volume will be measured on brain CT/MRI in mL using semi-automated volumetric software.
24 hours
Hematoma Expansion at 24 Hours
Periodo de tiempo: 24 hours
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.
24 hours

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Serious Adverse Events
Periodo de tiempo: From randomization through 180 days after randomization
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.
From randomization through 180 days after randomization
Incidence of Adverse Events of Special Interest
Periodo de tiempo: From randomization through 180 days after randomization
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.
From randomization through 180 days after randomization

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fudan University

Colaboradores

Guangdong Provincial Hospital of Traditional Chinese Medicine
Chinese PLA General Hospital
Huashan Hospital
Beijing University of Chinese Medicine
Hubei College of Traditional Chinese Medicine

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

31 de enero de 2029

Finalización del estudio (Estimado)

30 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

27 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de agosto de 2026

Publicado por primera vez (Actual)

7 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • APEX-STROKE CALM-ICH DOMAIN

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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