Acute Ischemic StrokePhase 3NCT04475328
Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke (ANGONG TRIAL)
A Phase 3 study testing AngongNiuhuang pill and Standard treatment in people with Acute Ischemic Stroke, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular diseases. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, inhibit capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, reduce oxidative stress injury, thus… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- AngongNiuhuang pill and Standard treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Jul 2022
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participates aged 40-80 years.
- Diagnosis with acute ischemic stroke.
- Diagnosis with acute cerebral infarctions of internal carotid artery system.
- 10≤ Baseline NIHSS <20.
- Time of onset ≤36h.
- Provision of informed consent.
Who cannot join
- Not suitable for taking this medicine according to the judgement of consulting traditional Chinese medical doctor.
- Suffering from intracranial tumors, encephalitis, subarachnoid hemorrhage and other brain organic diseases.
- Patients with hemorrhagic transformation after cerebral infarction.
- Received or planned to receive endovascular treatment, including thrombectomy, ultra early thrombectomy and stenting.
- Received or planned to receive decompression craniectomy.
- With mRS score >1 before onset of this episode.
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- Participates who cannot tolerate the MRI scans, such as Using a pacemaker or automatic defibrillator or having claustrophobia.
- With thrombocytopenia (<100 x10^9/L), hematologic diseases or other systemic bleeding tendency.
- With Alanine transaminase or Aspartate aminotransferase >1.5 times than normal upper limit or Creatinine >1.5 times than normal upper limit.
- Allergic to ingredients of AngongNiuhuang pill.
- Received AngongNiuhuang pill within 1 month.
- Participates who plan to become pregnant within 3 months, or women of childbearing age with negative pregnancy test but refuse to accept contraception; during pregnancy or lactation.
- Participates in other clinical trials within 30 days before randomization or currently involved in other clinical trails.
- Participates with a life expectancy less than 3 months.
- Incapable to follow this study due to mental illness, cognitive or emotional disorders.
- Participates are not eligible for this clinical trial as evaluated by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology,Peking Union Medical College Hospital,Shuaifuyuan 1,Dong Cheng District. Beijing
Beijing, Beijing Municipality, 100730
About this study
Official title: Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke
AngongNiuhuang pill has obvious effects on the cardiovascular and cerebrovascular diseases. Pharmacological experiments confirmed that AngongNiuhuang pill can protect blood-brain barrier, inhibit capillary permeability, improve the tolerance of cerebral ischemia and hypoxia, reduce oxidative stress injury, thus protecting brain tissue. Clinical studies have also confirmed that AngongNiuhuang pill can increase the GCS score, reduce coma, improve nerve function defect and promote nerve function recovery. The primary purpose of this trial was to evaluate the difference in the volume of cerebral infarction and cerebral edema between Angong Niuhuang pill and placebo in patients with ischemic stroke at 14 days compared with the baseline.
Read the detailed description
This trial is a prospective, randomized, double-blinded, placebo parallel controlled, multicenter trial. Patients who met the inclusion and exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive AngongNiuhuang pill 1pill qd/day for 5-day; 2) the other group will receive Placebo of AngongNiuhuang pill 1pill qd/day for 5-day. The primary purpose of this trial was to evaluate the difference in the volume of cerebral infarction and cerebral edema between Angong Niuhuang pill and placebo in patients with ischemic stroke at 14 days compared with the baseline. The study was consisted of six visits, including the day of randomization, 2 days, 3-6 days, 7 days (the endap time of the therapy), 14 days, and 90 days (the endap time of the follow-up). Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The period of the trial is from August 2020 to October 2021, and 120 subjects are planned to be recruited from 10 centers in China. All the related investigative organizations and individuals will obey the Declaration of Helsinki and Chinese Guard-cell protoplast (GCP) standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study.
- Conditions
- Acute Ischemic Stroke
- Being tested
- AngongNiuhuang pill, Placebo of AngongNiuhuang pill, Standard treatment
- Keywords
- Acute Ischemic Stroke, AngongNiuhuang Pill
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngongNiuhuang pillDrug
Also called Angong Niuhuang Wan
This group will receive AngongNiuhuang pill 1pill qd/day for 5-day.
Placebo of AngongNiuhuang pillDrug
Also called Placebo of Angong Niuhuang Wan
This group will receive placebo of AngongNiuhuang pill 1pill qd/day for 5-day.
Standard treatmentOther
The other treatments according to guidelines for standard treatment of acute ischemic stroke
| Study group | Role | What they receive |
|---|---|---|
| AngongNiuhuang | Experimental | Drugs : AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke. Receives: Drug: AngongNiuhuang pill; Other: Standard treatment |
| Placebo of AngongNiuhuang | Placebo comparator | Drugs : Placebo of AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke. Receives: Drug: Placebo of AngongNiuhuang pill; Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral infarction volume
Changes in cerebral infarction volume on Day 14 of the treatment from baseline.
Measured: 14 days
Cerebral edema volume
Changes in cerebral edema volume on Day 14 of the treatment from baseline.
Measured: 14 days
The proportion of the patients with Severity Adverse Events within 90 days of the treatment.
Severity Adverse Events
Measured: 90 days
Secondary outcomes (14)
Cerebral infarction volume
Changes in cerebral infarction volume on Day 90 of the treatment from baseline.
Measured: 90 days
Cerebral edema volume
Changes in cerebral edema volume on Day 90 of the treatment from baseline.
Measured: 90 days
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point on the Day 14 and 90 of treatment.
Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS scores between 3 to 6 points are considered to be poor functional outcome.
Measured: 14 days, 90 days
Changes in NIHSS score on Day 14 and 90 of the treatment from baseline.
The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Measured: 14 days, 90 days
Changes in Glasgow Coma Score (GCS) on the Day 7 and 14 of the treatment from baseline.
We will use the GCS score to evaluate the degree of coma. The GCS have three domain items (open-eye response, speech response, and movement). The maximum possible score is 15, with the minimum score being a 3.
Measured: 7 days, 14 days
Changes of biomarker (hs-CRP)
Evaluation of the change in hs-CRP on Day 7 of the treatment.
Measured: 7 days
Changes of biomarker (MMP-9)
Evaluation of the change in MMP-9 on Day 7 of the treatment.
Measured: 7 days
Changes of biomarker (S-100B)
Evaluation of the change in S-100B on Day 7 of the treatment.
Measured: 7 days
Changes of biomarker (NSE)
Evaluation of the change in NSE on Day 7 of the treatment.
Measured: 7 days
The proportion of the patients with Severity Adverse Events within 7 days of the treatment.
Severity Adverse Events
Measured: 7 days
Changes in toxicology index including mercury and arsenic on Day 7 of the treatment.
toxicology index
Measured: 7 days
The proportion of the patients with Adverse Events within 7 and 90 days of the treatment.
Adverse Events
Measured: 7 days, 90 days
The proportion of the patients with All-cause mortality within 7 and 90 days of the treatment.
All-cause mortality
Measured: 7 days, 90 days
The proportion of the patients with Combined vascular events within 7 and 90 days of the treatment.
Combined vascular events
Measured: 7 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Oct 2020
- Primary completion1 May 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Peng, Peking Union Medical College Hospital
- Investigators
- Bin Peng, MD, Principal investigator, Peking Union Medical College Hosptial, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475328
- Sponsor's protocol ID
- PUMCH-AGNH2020
- Status last verified
- Sep 2023
- First submitted
- 10 Jul 2020
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39501831