NCT07882030Toborzás még nem indult
Early Administration of Angong Niuhuang Pill for Disabling Acute Ischemic Stroke (EAGER Trial)
Efficacy and Safety of Early Administration of Angong Niuhuang Pill in Patients With Disabling Acute Ischemic Stroke: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 20.
Rövid összefoglaló (regiszter, angolul)
This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of early administration of Angong Niuhuang Pill in patients with disabling acute ischemic stroke. Approximately 1,200 eligible participants will be randomly assigned in a 1:1 ratio to receive Angong Niuhuang Pill or a matching placebo for 5 consecutive days. Eligible participants will be adults aged 18 to 80 years with imaging-confirmed acute ischemic stroke involving the anterior circulation, a baseline National Institutes of Health Stroke Scale (NIHSS) score of 10 to 19, symptom onset or last known well within 24 hours before randomization, and a pre-stroke modified Rankin Scale (mRS) score of 0 or 1. The primary efficacy outcome is the proportion of participants achieving functional independence at 90 days after randomization, defined as an mRS score of 0 to 2. Secondary outcomes include excellent functional outcome, the distribution of mRS scores at 90 days, change in the Barthel Index, changes in NIHSS scores, neurological improvement, and symptomatic intracranial hemorrhage. Safety outcomes include serious adverse events, all-cause mortality, and changes in hepatic and renal laboratory parameters.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1200 (tervezett)
- Első benyújtás
- 2026. szept. 27.
- Kezdés
- 2026. okt.
- Elsődleges befejezés
- 2027. júl.
- Fő szponzor
- Xuanwu Hospital, Beijing
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT07882030
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 1200
- 2026. okt. és az elsődleges befejezés (2027. júl.) között
- 1 helyszín, 1 országban
- 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
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Severe drug or alcohol abuse.
- Participation in another clinical trial within 3 months before screening.
- Use of Angong Niuhuang Pill within 1 month before screening.
Más betegség
- Presence of symptoms or clinical conditions considered unsuitable for administration of Angong Niuhuang Pill, including axillary body temperature below 36°C, systolic blood pressure below 120 mmHg, or loose stool within 24 hours before stroke onset, characterized by loose consistency and increased water content.
- Brain imaging findings indicating encephalitis, brain tumor, brain abscess, or another condition that may mimic acute ischemic stroke, or evidence of epidural hematoma, intracranial hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, or other intracranial bleeding.
- Known allergy to Angong Niuhuang Pill or any contraindication to its administration.
- History of arterial aneurysm, including intracranial or peripheral arterial aneurysm.
- History of psychotic disorder or dementia.
- Severe organ dysfunction or other serious systemic disease; any active malignancy or ongoing anticancer treatment; or life expectancy of less than 3 months.
- Clinically significant hypersensitivity or a history of allergy to two or more drugs or foods.
- Inability to understand and/or comply with study procedures or follow-up requirements because of psychiatric, cognitive, or other disorders.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
Laborértékek
- Thrombocytopenia, defined as a platelet count below 100 × 10\^9/L; hematologic disease or other systemic bleeding tendency; or lower-extremity deep vein thrombosis.
- Severe hepatic or renal dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 1.5 times the upper limit of normal, or serum creatinine more than 1.5 times the upper limit of normal.
Egyéb
- Patients who have undergone or are planned to undergo decompressive craniectomy.
- Pregnancy or breastfeeding at screening.
Kiket keres a vizsgálat
- Age 18 to 80 years, inclusive.
- Acute ischemic stroke involving the anterior circulation, confirmed by brain computed tomography (CT) or magnetic resonance imaging (MRI).
- Baseline National Institutes of Health Stroke Scale (NIHSS) score of 10 to 19, inclusive.
- Symptom onset or last known well within 24 hours before randomization.
- Pre-stroke modified Rankin Scale (mRS) score of 0 or 1.
- The participant or legally authorized representative understands the study procedures and voluntarily provides written informed consent.
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Xuanwu Hospital | Beijing | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.