Xingnaojing for Mild-to-severe Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— XMAS-2  

Official title:

Xingnaojing for Mild-to-severe Acute Ischemic Stroke (XMAS-2): A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04150835
• Other study ID #: 2018YFC1705001
• Status: Recruiting
• Phase: Phase 4
• Start date: March 19, 2020
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Dongzhimen Hospital, Beijing
• Contact: Ying Gao, MD
• Phone: 0086-010-84013209
• Email: gaoying973[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Acute ischemic stroke;

• Symptom onset within 24 hours;

• Age = 18 and = 80 years;

• NIHSS score = 4 and = 25;

• Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

• Planned or already receiving intravenous thrombolysis or endovascular treatment;

• Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;

• Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score = 2) ;

• Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);

• Other conditions that lead to motor dysfunction (e.g., severe osteoarthrosis, rheumatoid arthritis);

• Significant renal or hepatic insufficiency (defined as a serum creatinine concentration, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);

• Life expectancy of 3 months or less due to other life-threatening illness (e.g.,advanced cancer)

• Other conditions that render outcomes or follow-up unlikely to be assessed;

• Known to be pregnant or breastfeeding;

• Currently receiving an investigational drug;

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke
• Stroke, Acute
• Stroke, Ischemic

Intervention

Drug:
• Xingnaojing injection
Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
• Xingnaojing placebo injection
Xingnaojing placebo injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.

Other:
• Standard care
Guidelines-based standard care for acute ischemic stroke.

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing

Sponsors (37)

Lead Sponsor

Collaborator

Dongzhimen Hospital, Beijing

Anshan Central Hospital, Beijing Shuyi Hospital, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Guangzhou Hospital of Traditional Chinese Medicine, Haikou People's Hospital, Hubei Hospital of Traditional Chinese Medicine, Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, Liling Hospital of Traditional Chinese Medicine, Longhua Hospital, Peking University Third Hospital, People's Hospital of Quzhou, Second Affiliated Hospital of Wenzhou Medical University, Shandong University of Traditional Chinese Medicine, Taizhou Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Changzhi Academy of TCM, The Affiliated Hospital of Liaoning University of TCM, The Affiliated Hospital of Shaanxi University of Chinese Medicine, The Airport Hospital of Shunyi District Beijing, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The First Affiliated Hospital of Guangxi University of Chinese Medicine, The First Affiliated Hospital of Guizhou University of TCM, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The First Hospital of Jilin University, The First Hospital of Qiqihar City, The NO.4 People's Hospital of Hengshui, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Second Hospital of Hebei Medical University, The Second People's Hospital of Anhui Province, The Third Affiliated Hospital of Shenzhen University, The Third Hospital of Xi'an City, The third people's Hospital of Hubei Province, Tianshui Hospital of Traditional Chinese Medicine, Yantai Yuhuangding Hospital, Zhejiang Provincial Hospital of TCM, Zhejiang Provincial Tongde Hospital, Zibo Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS).	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The recurrence rate of cerebrovascular events	The recurrence rate of cerebrovascular events within 90 days.	Within 90 days
Secondary	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
Secondary	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