NCT07752719Not yet recruitingPhase 3
APEX-STROKE CALM-ICH Domain
Chinese Angong Niuhuang for Acute Medical Management of Intracerebral Hemorrhage (CALM-ICH) Domain of the APEX-STROKE Adaptive Platform Trial
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1100 (estimated)
- First submitted
- 27 Jul 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Fudan University
- Diseases
- Stroke
- NCT number
- NCT07752719
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1100
- From 1 Oct 2026 to the primary completion date, 31 Jan 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.