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

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongzhimen Hospital, Beijing
• Collaborators: Beijing Chao Yang Hospital; Beijing Emergency Medical Center; Beijing Tiantan Hospital; Cangzhou Hospital of Integrated Medicine; China-Japan Union Hospital, Jilin University; Chongqing Hospital of Traditional Chinese Medicine; 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; Jilin University; 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 Jilin University; The First Hospital of Wuhan; The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine; The Second Affiliated Hospital of Shandong University of TCM; 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

Criteria

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.