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

24. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1100

Fase

  • Fase 3

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Early Angong Niuhuang Pill (ANP) treatment
Participants in this arm receive early treatment with ANP Within 6 hours of onset.
Legemiddel: 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.
Placebo komparator: Placebo
Participants in this arm will not receive ANP and will receive a matching placebo.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
modified Rankin scale (mRS) scores
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
NIHSS score
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Serious Adverse Events
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fudan University

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. oktober 2026

Primær fullføring (Antatt)

31. januar 2029

Studiet fullført (Antatt)

30. juni 2029

Datoer for studieregistrering

Først innsendt

27. juli 2026

Først innsendt som oppfylte QC-kriteriene

4. august 2026

Først lagt ut (Faktiske)

7. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • APEX-STROKE CALM-ICH DOMAIN

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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