StrokePhase 3CALM-ICHNCT07752719
APEX-STROKE CALM-ICH Domain
A Phase 3 study testing Angong Niuhuang Pills (ANP) in people with Stroke and Intracerebral Hemorrhage, run by Fudan University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Intracerebral Hemorrhage
- What is being tested?
- Angong Niuhuang Pills (ANP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: 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.
Read more
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.
- Conditions
- Stroke, Intracerebral Hemorrhage
- Being tested
- Angong Niuhuang Pills (ANP), Placebo
- Medical subject headings
- Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angong Niuhuang Pills (ANP)Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Angong Niuhuang Pill (ANP) treatment | Experimental | Participants in this arm receive early treatment with ANP Within 6 hours of onset. Receives: Drug: Angong Niuhuang Pills (ANP) |
| Placebo | Placebo comparator | Participants in this arm will not receive ANP and will receive a matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin scale (mRS) scores
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.
Measured: 180 days
Secondary outcomes (6)
Hematoma volume
Hematoma volume will be measured on brain CT/MRI in mL using semi-automated volumetric software.
Measured: 24 hours
Hematoma Expansion at 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.
Measured: 24 hours
NIHSS score
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.
Measured: 24 hours and 7 day
Mortality
All-cause mortality will be reported as the number and proportion of participants who died from any cause by 180 days after randomization.
Measured: 180 days
Favorable functional outcome (mRS 0-2 and mRS 0-3)
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).
Measured: 180 days
Health-Related quality of Life assessed by EQ-5D
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Chinese PLA General Hospital, Beijing University of Chinese Medicine, Hubei College of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752719
- Sponsor's protocol ID
- APEX-STROKE CALM-ICH DOMAIN
- Acronym
- CALM-ICH
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Angong Niuhuang for Acute Medical Management of Intracerebral Hemorrhage (CALM-ICH) Domain of the APEX-STROKE Adaptive Platform Trial
- ClinicalTrials.gov ID
- NCT07752719
- Acronym / sponsor ID
- CALM-ICH / APEX-STROKE CALM-ICH DOMAIN
- Conditions
- Stroke, Intracerebral Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Huashan Hospital, Chinese PLA General Hospital, Beijing University of Chinese Medicine, Hubei College of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Angong Niuhuang Pill (ANP) treatment | Experimental | Drug: Angong Niuhuang Pills (ANP)Participants in this arm receive early treatment with ANP Within 6 hours of onset. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm will not receive ANP and will receive a matching placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- In-Hospital Setting
- Prehospital (Ambulance) Setting
Key exclusion criteria (16 listed)
- In-Hospital Setting
- Prehospital (Ambulance) Setting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Early Angong Niuhuang Pill (ANP) treatment |
| PlaceboMatching 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. | Drug | Placebo |
Primary outcome
modified Rankin scale (mRS) scores
Time frame: 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.
6 secondary outcomes
Hematoma volume
Time frame: 24 hours
Hematoma Expansion at 24 Hours
Time frame: 24 hours
NIHSS score
Time frame: 24 hours and 7 day
Mortality
Time frame: 180 days
Favorable functional outcome (mRS 0-2 and mRS 0-3)
Time frame: 180 days
Health-Related quality of Life assessed by EQ-5D
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Angong Niuhuang Pills (ANP) in people with Stroke and Intracerebral Hemorrhage, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin scale (mRS) scores (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.