APEX-STROKE CALM-ICH Domain

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.

NCT Number	NCT07752719
Lead Sponsor	Fudan University 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
Conditions	Stroke, Intracerebral Hemorrhage
Enrollment	1,100 participants
Start Date	2026-09-01
Primary Completion	2029-06-30 (estimated)
Study Completion	2030-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-07