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NCT07882030

Early Administration of Angong Niuhuang Pill for Disabling Acute Ischemic Stroke (EAGER Trial)

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2026-10

Completion Date

2027-10

Last Updated

2026-10-20

Healthy Volunteers

Conditions

Acute Ischemic Stroke

Interventions

DRUG

Angong Niuhuang Pill

Participants will receive Angong Niuhuang Pill at a dose of 1 pill (3 g) once daily for 5 consecutive days. The study medication will be administered orally or through a nasogastric tube.

DRUG

Angong Niuhuang Pill Matching Placebo

Participants will receive a matching placebo at a dose of 1 pill (3 g) once daily for 5 consecutive days. The matching placebo is manufactured to resemble Angong Niuhuang Pill in appearance, odor, taste, dosage form, and packaging. The placebo contains 5% Angong Niuhuang Pill and no other medicinal ingredients. The study medication will be administered orally or through a nasogastric tube.

Inclusion Criteria: 1. Age 18 to 80 years, inclusive. 2. Acute ischemic stroke involving the anterior circulation, confirmed by brain computed tomography (CT) or magnetic resonance imaging (MRI). 3. Baseline National Institutes of Health Stroke Scale (NIHSS) score of 10 to 19, inclusive. 4. Symptom onset or last known well within 24 hours before randomization. 5. Pre-stroke modified Rankin Scale (mRS) score of 0 or 1. 6. The participant or legally authorized representative understands the study procedures and voluntarily provides written informed consent. Exclusion Criteria: 1. 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. 2. 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. 3. Known allergy to Angong Niuhuang Pill or any contraindication to its administration. 4. Patients who have undergone or are planned to undergo decompressive craniectomy. 5. History of arterial aneurysm, including intracranial or peripheral arterial aneurysm. 6. Thrombocytopenia, defined as a platelet count below 100 × 10\^9/L; hematologic disease or other systemic bleeding tendency; or lower-extremity deep vein thrombosis. 7. 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. 8. History of psychotic disorder or dementia. 9. Severe organ dysfunction or other serious systemic disease; any active malignancy or ongoing anticancer treatment; or life expectancy of less than 3 months. 10. Severe drug or alcohol abuse. 11. Clinically significant hypersensitivity or a history of allergy to two or more drugs or foods. 12. Pregnancy or breastfeeding at screening. 13. Participation in another clinical trial within 3 months before screening. 14. Inability to understand and/or comply with study procedures or follow-up requirements because of psychiatric, cognitive, or other disorders. 15. Use of Angong Niuhuang Pill within 1 month before screening. 16. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.

Locations (1)

Xuanwu Hospital

Beijing, China