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

NCT07882030 | Not Yet Recruiting

• 2 other identifiers: [2025]171-002-01Z241100009024041
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Functional Independence at 90 Days

  The proportion of participants achieving functional independence at 90 days after randomization, defined as a modified Rankin Scale (mRS) score of 0 to 2. The mRS ranges from 0 to 6, with higher scores indicating greater disability.

  90 ± 7 days after randomization

Secondary Outcomes (7)

• Excellent Functional Outcome at 90 Days

  90 ± 7 days after randomization

• Distribution of Modified Rankin Scale Scores at 90 Days

  90 ± 7 days after randomization

• Change in Barthel Index From Baseline to Day 90

  Baseline to 90 ± 7 days after randomization

• Change in NIHSS Score From Baseline to Day 14

  Baseline to day 14 ± 3 after randomization

• Neurological Improvement at Day 14

  Day 14 ± 3 after randomization

Other Outcomes (5)

• Serious Adverse Events Within 90 Days

  From randomization through day 90 ± 7

• All-Cause Mortality Within 90 Days

  Within 90 ± 7 days after randomization

• Change in Serum Alanine Aminotransferase From Baseline to Day 7

  Baseline to day 7 after randomization

Study Arms (2)

Angong Niuhuang Pill

EXPERIMENTAL

Drug: Angong Niuhuang Pill

Matching Placebo

PLACEBO COMPARATOR

Drug: Angong Niuhuang Pill Matching Placebo

Interventions

Angong Niuhuang Pill DRUG

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.

Angong Niuhuang Pill

Angong Niuhuang Pill Matching Placebo DRUG

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.

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients who have undergone or are planned to undergo decompressive craniectomy.
• History of arterial aneurysm, including intracranial or peripheral arterial aneurysm.
• 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.
• 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.
• Severe drug or alcohol abuse.
• Clinically significant hypersensitivity or a history of allergy to two or more drugs or foods.
• Pregnancy or breastfeeding at screening.
• Participation in another clinical trial within 3 months before screening.
• Inability to understand and/or comply with study procedures or follow-up requirements because of psychiatric, cognitive, or other disorders.
• Use of Angong Niuhuang Pill within 1 month before screening.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Beijing Tong Ren Tang Co., Ltd.: collaborator
• Beijing Tong Ren Tang Technology Development Co., Ltd.: collaborator

Study Sites (1)

Xuanwu Hospital

Beijing, China

Location

Related Publications (1)

• Li S, Wang A, Shi L, Liu Q, Guo X, Liu K, Wang X, Li J, Zhu J, Wu Q, Yang Q, Zhuang X, You H, Feng F, Luo Y, Li H, Ni J, Peng B. Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial. Chin Med J (Engl). 2025 Mar 5;138(5):579-588. doi: 10.1097/CM9.0000000000003133. Epub 2024 Nov 6.

  PMID: 39501831 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Angong Niuhuang Pill

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xiao Wu

CONTACT

+8615093669962; wuxiaoeducation@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators, and outcome assessors will be blinded to treatment allocation. The investigational product and matching placebo will be identical or sufficiently matched in appearance, color, odor, taste, dosage form, and packaging to maintain blinding. The 90-day modified Rankin Scale (mRS) will be assessed by trained outcome assessors who are blinded to treatment allocation. Drug dispensing will be performed by designated study personnel independent of clinical outcome assessment. Randomization and treatment allocation will be managed through the IWRS. Emergency unblinding will be permitted when knowledge of the treatment assignment is considered necessary for the medical management and safety of an individual participant, according to the prespecified emergency unblinding procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 20, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 20, 2026

Record last verified: 2026-09

Locations

CN (1)