APEX-STROKE CALM-ICH Domain

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Stroke, Intracerebral Hemorrhage

In brief

In this domain of APEX-STROKE, participants with acute intracerebral hemorrhage (ICH) who are considered suitable for non-surgical management and 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.

Key facts

Study ID

NCT07752719

Run by

Fudan University

People needed

1100

Starts

2026-09-01

Expected to finish

2030-02-28

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old;
• Symptom onset or last known well≤ 6 hours before randomization;
• Traditional Chinese Medicine syndrome consistent with heat-toxin internal accumulation: at least two of high fever, flushed face, restlessness, dry mouth, or rapid pulse;
• No surgical plan at the time of randomization;
• All corresponding eligibility criteria must be met according to the randomization setting:
• If randomized in the prehospital (ambulance) setting: AI model predicts ICH, FAST score ≥ 2 and GCS ≥ 8;
• If randomized in the emergency department: brain imaging confirms ICH, hematoma volume ≥ 10 mL, NIHSS score ≥ 8, and GCS score≥ 7;
• Provide written informed consent by patient (or approved surrogate)

You may not qualify if…

• Severe comorbid disease likely to interfere with trial treatment, follow-up, or outcome assessment, such as severe heart failure;
• History of epilepsy or seizure-like attack;
• Pregnancy or lactation;
• Subjects meeting any of the following criteria in the corresponding randomization setting shall be excluded:
• If randomized in the prehospital (ambulance) setting: blood glucose <2.8 mmol/L; head trauma within the previous 7 days; If randomized in the emergency department: severe hepatic or renal dysfunction, defined as serum creatinine ≥ 2 mg/dL or ALT/AST >3 times the upper limit of normal; secondary cause of hemorrhage, including arteriovenous malformation or other structural abnormality.

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.