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Not yet recruiting NCT07752719

APEX-STROKE CALM-ICH Domain

Phase III Interventional Stroke Intracerebral Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ANP + Standard Care, Placebo + Standard Care.
Who it may be relevant to
Registry conditions: Stroke, Intracerebral Hemorrhage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Chinese Angong Niuhuang for Acute Medical Management of Intracerebral Hemorrhage (CALM) Domain of the APEX-STROKE Adaptive Platform Trial

Overview

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.

Interventions

  • Drug ANP + Standard Care
    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 1
  • Drug Placebo + Standard Care
    Matching placebo administered in addition to guideline-based standard care, identical to 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.

Primary outcome measures

  • modified Rankin scale (mRS) scores [Time frame: 180 days]
Secondary outcome measures (5)
  • Hematoma volume and hematoma expansion [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]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07752719 · APEX-STROKE_CALM DOMAIN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗