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

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ClinicalTrials.gov Identifier: NCT02728180

Recruitment Status : Active, not recruiting

First Posted : April 5, 2016

Last Update Posted : October 4, 2019

Sponsor:

Collaborators:

Beijing Tiantan Hospital

Beijing Chao Yang Hospital

Guangdong Provincial Hospital of Traditional Chinese Medicine

The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine

Beijing Emergency Medical Center

The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Deyang People's Hospital

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

The Second Hospital of Hebei Medical University

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Hunan Academy of Chinese Medicine

First Hospital of Jilin University

China-Japan Union Hospital, Jilin University

Jiangmen Wuyi Hospital of Traditional Chinese Medicine

Jiangxi Provincial People's Hopital

Mianyang Central Hospital

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Shandong University of Traditional Chinese Medicine

Shaanxi Provincial People's Hospital

Shaanxi Provincial Hospital of Traditional Chinese Medicine

The Affiliated Hospital of Shaanxi University of Chinese Medicine

Tianshui Hospital of Traditional Chinese Medicine

Wuxi Hospital of Traditional Chinese Medicine

The First Hospital of Wuhan

Zhejiang Provincial Tongde Hospital

Zhejiang Provincial Hospital of TCM

Zhongshan Hospital Of Traditional Chinese Medicine

The Fifth People Hospital of Chongqing

Chongqing Traditional Chinese Medicine Hospital

Zibo Hospital of Traditional Chinese Medicine

Liling Hospital of Traditional Chinese Medicine

Cangzhou Hospital of Integrated Medicine

Yantai Yuhuangding Hospital

Information provided by (Responsible Party):

Ying Gao, Dongzhimen Hospital, Beijing

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Acute Ischemic Stroke	Drug: Xingnaojing injection Other: Standard care	Phase 4

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	720 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Xingnaojing for Moderate-to-severe Acute Ischemic Stroke (XMAS): A Multicenter, Prospective, Randomized, Open-label, Blinded Endpoint Clinical Trial.
Study Start Date :	March 2016
Estimated Primary Completion Date :	December 31, 2019
Estimated Study Completion Date :	December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Xingnaojing and standard care Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.	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.
Active Comparator: Standard care only Subjects will receive guidelines-based standard care only.	Other: Standard care Guidelines-based standard care for acute ischemic stroke.

Outcome Measures

Primary Outcome Measures :

Proportion of patients independent [ Time Frame: 90 days ]
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.

Secondary Outcome Measures :

Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups. [ Time Frame: Baseline and 10 days. ]
The NIHSS score ranges from 0 (best score) to 42 (worst score).
Activities of daily living [ Time Frame: 30 days and 90 days ]
Activities of daily living measured by Barthel Index score at 30 days and 90 days.
Patient reported outcome (PRO) scale of stroke [ Time Frame: 10 days ]
Patient reported outcome (PRO) scale of stroke at 10 days.
Early neurologic deterioration (END) [ Time Frame: Baseline and 48 hours ]
Early neurologic deterioration is defined as an increase of 3 points or more in the NIHSS score between baseline and 48 hours.
Symptomatic Intracranial Hemorrhage (sICH) [ Time Frame: 10 dyas ]
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.)
Deaths from any cause [ Time Frame: 10 days, 90 days ]
Number of deaths from any cause within 10 days and 90 days after symptom onset.
Safety end points - Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis). [ Time Frame: 10 days ]
Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
Cardiovascular events [ Time Frame: 90 days ]
Number of patients with recurrence of stroke or myocardial infarction.

Eligibility Criteria

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Ages Eligible for Study:	35 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations