Back to resultsEfficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke (ANGONG TRIAL)
Primary Purpose
Acute Ischemic Stroke
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
AngongNiuhuang pill
Placebo of AngongNiuhuang pill
Standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke, AngongNiuhuang Pill
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Department of Neurology,Peking Union Medical College Hospital,Shuaifuyuan 1,Dong Cheng District. Beijing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AngongNiuhuang
Placebo of AngongNiuhuang
Arm Description
Drugs : AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke.
Drugs : Placebo of AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke.
Outcomes
Primary Outcome Measures
Cerebral infarction volume
Changes in cerebral infarction volume on Day 14 of the treatment from baseline.
Cerebral edema volume
Changes in cerebral edema volume on Day 14 of the treatment from baseline.
The proportion of the patients with Severity Adverse Events within 90 days of the treatment.
Severity Adverse Events
Secondary Outcome Measures
Cerebral infarction volume
Changes in cerebral infarction volume on Day 90 of the treatment from baseline.
Cerebral edema volume
Changes in cerebral edema volume on Day 90 of the treatment from baseline.
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.
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.
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.
Changes of biomarker (hs-CRP)
Evaluation of the change in hs-CRP on Day 7 of the treatment.
Changes of biomarker (MMP-9)
Evaluation of the change in MMP-9 on Day 7 of the treatment.
Changes of biomarker (S-100B)
Evaluation of the change in S-100B on Day 7 of the treatment.
Changes of biomarker (NSE)
Evaluation of the change in NSE on Day 7 of the treatment.
The proportion of the patients with Severity Adverse Events within 7 days of the treatment.
Severity Adverse Events
Changes in toxicology index including mercury and arsenic on Day 7 of the treatment.
toxicology index
The proportion of the patients with Adverse Events within 7 and 90 days of the treatment.
Adverse Events
The proportion of the patients with All-cause mortality within 7 and 90 days of the treatment.
All-cause mortality
The proportion of the patients with Combined vascular events within 7 and 90 days of the treatment.
Combined vascular events
Full Information
NCT ID
NCT04475328
First Posted
July 10, 2020
Last Updated
September 8, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04475328
Brief Title
Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke (ANGONG TRIAL)
Official Title
Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Acute Ischemic Stroke, AngongNiuhuang Pill
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AngongNiuhuang
Arm Type
Experimental
Arm Description
Drugs : AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke.
Arm Title
Placebo of AngongNiuhuang
Arm Type
Placebo Comparator
Arm Description
Drugs : Placebo of AngongNiuhuang pill. The other treatments will provided according to guidelines for standard treatment of acute ischemic stroke.
Intervention Type
Drug
Intervention Name(s)
AngongNiuhuang pill
Other Intervention Name(s)
Angong Niuhuang Wan
Intervention Description
This group will receive AngongNiuhuang pill 1pill qd/day for 5-day.
Intervention Type
Drug
Intervention Name(s)
Placebo of AngongNiuhuang pill
Other Intervention Name(s)
Placebo of Angong Niuhuang Wan
Intervention Description
This group will receive placebo of AngongNiuhuang pill 1pill qd/day for 5-day.
Intervention Type
Other
Intervention Name(s)
Standard treatment
Intervention Description
The other treatments according to guidelines for standard treatment of acute ischemic stroke
Primary Outcome Measure Information:
Title
Cerebral infarction volume
Description
Changes in cerebral infarction volume on Day 14 of the treatment from baseline.
Time Frame
14 days
Title
Cerebral edema volume
Description
Changes in cerebral edema volume on Day 14 of the treatment from baseline.
Time Frame
14 days
Title
The proportion of the patients with Severity Adverse Events within 90 days of the treatment.
Description
Severity Adverse Events
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Cerebral infarction volume
Description
Changes in cerebral infarction volume on Day 90 of the treatment from baseline.
Time Frame
90 days
Title
Cerebral edema volume
Description
Changes in cerebral edema volume on Day 90 of the treatment from baseline.
Time Frame
90 days
Title
The proportion of patients with Modified Rankin Scale (mRS) score ≤ 2 point on the Day 14 and 90 of treatment.
Description
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.
Time Frame
14 days, 90 days
Title
Changes in NIHSS score on Day 14 and 90 of the treatment from baseline.
Description
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.
Time Frame
14 days, 90 days
Title
Changes in Glasgow Coma Score (GCS) on the Day 7 and 14 of the treatment from baseline.
Description
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.
Time Frame
7 days, 14 days
Title
Changes of biomarker (hs-CRP)
Description
Evaluation of the change in hs-CRP on Day 7 of the treatment.
Time Frame
7 days
Title
Changes of biomarker (MMP-9)
Description
Evaluation of the change in MMP-9 on Day 7 of the treatment.
Time Frame
7 days
Title
Changes of biomarker (S-100B)
Description
Evaluation of the change in S-100B on Day 7 of the treatment.
Time Frame
7 days
Title
Changes of biomarker (NSE)
Description
Evaluation of the change in NSE on Day 7 of the treatment.
Time Frame
7 days
Title
The proportion of the patients with Severity Adverse Events within 7 days of the treatment.
Description
Severity Adverse Events
Time Frame
7 days
Title
Changes in toxicology index including mercury and arsenic on Day 7 of the treatment.
Description
toxicology index
Time Frame
7 days
Title
The proportion of the patients with Adverse Events within 7 and 90 days of the treatment.
Description
Adverse Events
Time Frame
7 days, 90 days
Title
The proportion of the patients with All-cause mortality within 7 and 90 days of the treatment.
Description
All-cause mortality
Time Frame
7 days, 90 days
Title
The proportion of the patients with Combined vascular events within 7 and 90 days of the treatment.
Description
Combined vascular events
Time Frame
7 days, 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Peng, MD
Organizational Affiliation
Peking Union Medical College Hosptial, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology,Peking Union Medical College Hospital,Shuaifuyuan 1,Dong Cheng District. Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of AngongNiuhuang Pill in Patients With Acute Ischemic Stroke (ANGONG TRIAL)
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