Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

24 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

1100

Fase

  • Fase 3

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore placebo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
modified Rankin scale (mRS) scores
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
NIHSS score
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Serious Adverse Events
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fudan University

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

31 gennaio 2029

Completamento dello studio (Stimato)

30 giugno 2029

Date di iscrizione allo studio

Primo inviato

27 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 agosto 2026

Primo Inserito (Effettivo)

7 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • APEX-STROKE CALM-ICH DOMAIN

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi