APEX-STROKE CALM-ICH Domain
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- ANP + Standard Care
- Placebo + Standard Care
Treatment groups
1,100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Fudan University
Lead sponsor
Huashan Hospital
Collaborator
Chinese PLA General Hospital
Collaborator
Beijing University of Chinese Medicine
Collaborator
Hubei College of Traditional Chinese Medicine
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Source ClinicalTrials.gov