APEX-STROKE CALM-ICH Domain

Sponsor
Fudan University
Study ID
NCT07752719
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Intracerebral Hemorrhage
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Placebo — DRUG
    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 Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Jan 31, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
1,100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Early Angong Niuhuang Pill (ANP) treatment
    Participants in this arm receive early treatment with ANP Within 6 hours of onset.
  • Placebo Comparator: Placebo
    Participants in this arm will not receive ANP and will receive a matching placebo.

Primary Outcome Measure

modified Rankin scale (mRS) scores [ Time Frame: 180 days ]

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