NCT07752719Toborzás még nem indult3. fázis
APEX-STROKE CALM-ICH Domain
Chinese Angong Niuhuang for Acute Medical Management of Intracerebral Hemorrhage (CALM-ICH) Domain of the APEX-STROKE Adaptive Platform Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 26.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1100 (tervezett)
- Első benyújtás
- 2026. júl. 27.
- Kezdés
- 2026. okt. 1.
- Elsődleges befejezés
- 2029. jan. 31.
- Fő szponzor
- Fudan University
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07752719
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 1100
- 2026. okt. 1. és az elsődleges befejezés (2029. jan. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Más betegség
- In-Hospital Setting
- Secondary ICH, including ICH associated with cerebrovascular malformations or other structural abnormalities, brain tumors, head trauma, hemorrhagic transformation of cerebral infarction, or bleeding following thrombolysis or thrombectomy.
- Severe comorbidities that may interfere with study treatment, follow-up, or outcome assessment (e.g., severe heart failure, malignant tumors, chronic obstructive pulmonary disease, or severe pre-existing disability).
- Known allergy to Angong Niuhuang Wan or any of its ingredients.
- Pregnancy or breastfeeding.
- History of severe chronic kidney disease or hepatic failure.
- Very high likelihood of death within 7 days or poor anticipated adherence to study treatment or follow-up.
Laborértékek
- Prehospital (Ambulance) Setting
- Blood glucose <2.8 mmol/L.
- History of head trauma within the previous 7 days.
- History of seizures or seizure-like episodes.
- Severe comorbidities that may interfere with study treatment, follow-up, or outcome assessment (e.g., severe heart failure, malignant tumors, chronic obstructive pulmonary disease, or severe pre-existing disability).
- Known allergy to Angong Niuhuang Wan or any of its ingredients.
- Pregnancy or breastfeeding.
- History of severe chronic kidney disease or hepatic failure.
- Very high likelihood of death within 7 days or poor anticipated adherence to study treatment or follow-up.
Kiket keres a vizsgálat
- In-Hospital Setting
- Age ≥18 years.
- Symptom onset or last known well ≤6 hours before randomization. Intracerebral hemorrhage (ICH) confirmed by brain imaging, with a hematoma volume ≥10 mL.
- National Institutes of Health Stroke Scale (NIHSS) score ≥8.
- Glasgow Coma Scale (GCS) score ≥8.
- Traditional Chinese medicine (TCM) syndrome consistent with internal accumulation of heat-toxin, defined by the presence of at least 2 of the following: high fever, facial flushing, agitation, dry mouth, and rapid pulse.
- No surgery performed at the time of randomization.
- Written informed consent obtained from the participant or their legally authorized representative.
- Prehospital (Ambulance) Setting
- Age ≥18 years.
- Symptom onset or last known well ≤6 hours before randomization.
- Predicted to have ICH by an artificial intelligence-based model.
- FAST score ≥2.
- TCM syndrome consistent with internal accumulation of heat-toxin, defined by the presence of at least 2 of the following: high fever, facial flushing, agitation, dry mouth, and rapid pulse.
- Written informed consent obtained from the participant or their legally authorized representative.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.