Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
| Beijing Shuyi Hospital | OTHER |
| The Airport Hospital of Shunyi District Beijing | UNKNOWN |
| Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine |
Not provided
Not provided
Not provided
Not provided
The main purpose of this trial is to determine whether Xingnaojing, intravenously administered within 24 hours of symptom onset, improves the daily living ability of acute ischemic stroke at 90 days.
The XMAS-2 study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Xingnaojing will improve the daily living ability of acute ischemic stroke at 90 days. Xingnaojing will be compared to placebo, combined with guidelines-based standard care in patients with acute ischemic stroke within 24 hours of symptom onset. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 90 days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xingnaojing | Experimental | Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. |
|
| Placebo | Placebo Comparator | Subjects will receive intravenously administered Xingnaojing placebo, combined with guidelines-based standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xingnaojing injection | Drug | Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients independent. | Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.The Modified Rankin Scale Score ranges from 0 (best score) to 6 (worst score). | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Early neurological deterioration. | The early neurologic deterioration is defined as an increase of 1 points or more in the National Institute of Health Stroke Scale (NIHSS) score between baseline and 3 days. The NIHSS score ranges from 0 (best score) to 42 (worst score). | Baseline and 3 days |
| Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Gao, MD | Contact | 0086-010-84013209 | gaoying973@126.com | |
| Tiantian Meng, MD | Contact | (+86)17812171713 | 17812171713@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Gao, MD | Dongzhimen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital | Recruiting | Beijing | Beijing Municipality | 100700 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594497 | xingnaojing |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| OTHER |
| The NO.4 People's Hospital of Hengshui | UNKNOWN |
| The Second Hospital of Hebei Medical University | OTHER |
| The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
| Shaanxi Hospital of Traditional Chinese Medicine | OTHER |
| Tianshui Hospital of Traditional Chinese Medicine | UNKNOWN |
| The Affiliated Hospital of Changzhi Academy of TCM | UNKNOWN |
| Zibo Hospital of Traditional Chinese Medicine | OTHER |
| Yantai Yuhuangding Hospital | OTHER |
| Shandong University of Traditional Chinese Medicine | OTHER |
| Zhejiang Provincial Hospital of TCM | OTHER |
| Zhejiang Provincial Tongde Hospital | OTHER |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| People's Hospital of Quzhou | OTHER |
| Longhua Hospital | OTHER |
| The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | OTHER |
| Taizhou Hospital of Traditional Chinese Medicine | OTHER_GOV |
| The First Affiliated Hospital of Guizhou University of TCM | UNKNOWN |
| Guangzhou Hospital of Traditional Chinese Medicine | UNKNOWN |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Liling Hospital of Traditional Chinese Medicine | UNKNOWN |
| Hunan Academy of Traditional Chinese Medicine Affiliated Hospital | UNKNOWN |
| Hubei Hospital of Traditional Chinese Medicine | OTHER |
| The First Hospital of Jilin University | OTHER |
| Anshan Central Hospital | OTHER |
| Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | OTHER |
| The First Hospital of Qiqihar City | UNKNOWN |
| Haikou People's Hospital | OTHER |
| The Second People's Hospital of Anhui Province | OTHER |
| The Third Affiliated Hospital of Shenzhen University | UNKNOWN |
| The Third People's Hospital of Hubei Province | OTHER |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
| The Third Hospital of Xi'an City | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
| Xingnaojing placebo injection | Drug | Xingnaojing placebo injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days. |
|
| Standard care | Other | Guidelines-based standard care for acute ischemic stroke. |
|
Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups.The NIHSS score ranges from 0 (best score) to 42 (worst score). |
| Baseline and 10 days |
| Patient reported outcome | Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 36(best score) to 180 (worst score). | 10 days |
| State of consciousness | The state of consciousness evaluated by Glasgow Coma Scale at 7 days. The Glasgow score ranges from 3(worst score) to 15 (best score). | 48 hours and 7 days |
| Activities of daily living | Activities of daily living will be measured by Barthel Index score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score). | 30 days and 90 days |
| The proportion of patients independent at 30 days. | The proportion of patients independent will be evaluated by mRS at 30 days.The mRS score ranges from 0 (best score) to 6 (worst score). | 30 days |
| The recurrence rate of cerebrovascular events | The recurrence rate of cerebrovascular events within 90 days. | Within 90 days |
| Stroke related deaths and deaths from any cause | Stroke related deaths and deaths from any cause within 10 days and 90 days after symptom onset. | Within 10 days and 90 days |
| Safety end points | Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis). | 10 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |