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

Prior treatment

• 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.

Other illness

• 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.

Lab values

• 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.

Other

• Patients who have undergone or are planned to undergo decompressive craniectomy.
• Pregnancy or breastfeeding at screening.

• 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.