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

October 2, 2019 updated by: Ying Gao, Dongzhimen Hospital, Beijing

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
720

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100700
        • Dongzhimen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Xingnaojing and standard care
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Other: Standard care
Guidelines-based standard care for acute ischemic stroke.
Drug: Xingnaojing injection
Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.
ACTIVE_COMPARATOR: Standard care only
Subjects will receive guidelines-based standard care only.
Other: Standard care
Guidelines-based standard care for acute ischemic stroke.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients independent
Time Frame: 90 days
Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline and 10 days.
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.
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.
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.
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.)
10 dyas
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.
10 days, 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).
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).
10 days
Cardiovascular events
Time Frame: 90 days
Number of patients with recurrence of stroke or myocardial infarction.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dongzhimen Hospital, Beijing

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangdong Provincial Hospital of Traditional Chinese Medicine
Beijing Tiantan Hospital
The Second Hospital of Hebei Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Beijing Chao Yang Hospital
Shaanxi Provincial People's Hospital
The First Hospital of Jilin University
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
China-Japan Union Hospital, Jilin University
Yantai Yuhuangding Hospital
Mianyang Central Hospital
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Jiangxi Provincial People's Hopital
Zhejiang Provincial Hospital of TCM
Zhejiang Provincial Tongde Hospital
Chongqing Traditional Chinese Medicine Hospital
Shandong University of Traditional Chinese Medicine
Beijing Emergency Medical Center
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhongshan Hospital Of Traditional Chinese Medicine
The First Hospital of Wuhan
Shaanxi Provincial Hospital of Traditional Chinese Medicine
Wuxi Hospital of Traditional Chinese Medicine
The Affiliated Hospital of Shaanxi University of Chinese Medicine
Tianshui Hospital of Traditional Chinese Medicine
Zibo Hospital of Traditional Chinese Medicine
Liling Hospital of Traditional Chinese Medicine
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Deyang People's Hospital
Hunan Academy of Chinese Medicine
Jiangmen Wuyi Hospital of Traditional Chinese Medicine
The Fifth People Hospital of Chongqing
Cangzhou Hospital of Integrated Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014BAI10B05-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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