Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS)

Acute Ischemic Stroke Clinical Trial

— XMAS  

Official title:

Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS): A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Clinical Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02728180
• Other study ID #: 2014BAI10B05-01
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2019
• Source: Dongzhimen Hospital, Beijing
• Contact: n/a
• 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 3-month outcome in participants with acute ischemic stroke.

Description:

Xingnaojing is widely used in China, but there is lack of high-quality evidence of its efficacy for acute ischemic stroke currently. The primary hypothesis of this trial is that Xingnaojing will increase the proportion of people alive and independent at three months. Xingnaojing, combined with guidelines-based standard care, will be compared to standard care alone in patients with acute ischemic stroke within 24 hours of symptom onset. All patients will have a National Institutes of Health Stroke Scale (NIHSS) entry score of 5-20. Patients in each group will be treated according to the guidelines-based standard care, including intravenous thrombolysis if appropriate. The primary outcome will be determined at 3 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 720
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• Acute ischemic stroke within 24 hours of symptom onset.

• National Institutes of Health Stroke Scale score = 5 and = 20.

• Age = 35 and = 80 years.

• Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

• Planned or already received endovascular treatment.

• Suspected secondary stroke caused by tumor, brain trauma, or hematologic diseases.

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

• 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, or aspartate aminotransferase value that is twice greater than the upper limit of normal).

• Life expectancy of 90 days 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

Intervention

Drug:
• Xingnaojing injection
Xingnaojing injection (20 ml), 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 (34)

Lead Sponsor

Collaborator

Dongzhimen Hospital, Beijing

Beijing Chao Yang Hospital, Beijing Emergency Medical Center, Beijing Tiantan Hospital, Cangzhou Hospital of Integrated Medicine, China-Japan Union Hospital, Jilin University, Chongqing Traditional Chinese Medicine Hospital, Deyang People's Hospital, First Hospital of Jilin University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hunan Academy of Chinese Medicine, Jiangmen Wuyi Hospital of Traditional Chinese Medicine, Jiangxi Provincial People's Hopital, Liling Hospital of Traditional Chinese Medicine, Mianyang Central Hospital, Shaanxi Provincial Hospital of Traditional Chinese Medicine, Shaanxi Provincial People's Hospital, Shandong University of Traditional Chinese Medicine, The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, The Affiliated Hospital of Shaanxi University of Chinese Medicine, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Fifth People Hospital of Chongqing, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The First Hospital of Wuhan, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine, The Second Hospital of Hebei Medical University, Tianshui Hospital of Traditional Chinese Medicine, Wuxi Hospital of Traditional Chinese Medicine, Yantai Yuhuangding Hospital, Zhejiang Provincial Hospital of TCM, Zhejiang Provincial Tongde Hospital, Zhongshan Hospital Of Traditional Chinese Medicine, Zibo Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Lai X, Cao K, Kong L, Liu Q, Gao Y; XMAS study investigators. Xingnaojing for Moderate-to-severe Acute ischemic Stroke (XMAS): study protocol for a randomized controlled trial. Trials. 2017 Oct 16;18(1):479. doi: 10.1186/s13063-017-2222-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients independent	Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.	90 days
Secondary	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	Activities of daily living	Activities of daily living measured by Barthel Index score at 30 days and 90 days.	30 days and 90 days
Secondary	Patient reported outcome (PRO) scale of stroke	Patient reported outcome (PRO) scale of stroke at 10 days.	10 days
Secondary	Early neurologic deterioration (END)	Early neurologic deterioration is defined as an increase of 3 points or more in the NIHSS score between baseline and 48 hours.	Baseline and 48 hours
Secondary	Symptomatic Intracranial Hemorrhage (sICH)	Symptomatic Intracranial Hemorrhage (sICH) within 10 days of stroke onset. (Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH.)	10 dyas
Secondary	Deaths from any cause	Number of deaths from any cause within 10 days and 90 days after symptom onset.	10 days, 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).	Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).	10 days
Secondary	Cardiovascular events	Number of patients with recurrence of stroke or myocardial infarction.	90 days