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

Unknown

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

Interventional

Enrollment (Anticipated)

720

Phase

  • 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

    • 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

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
Intervention / Treatment
EXPERIMENTAL: Xingnaojing and standard care
Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Guidelines-based standard care for acute ischemic stroke.
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.
Guidelines-based standard care for acute ischemic stroke.

What is the study measuring?

Primary Outcome Measures

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

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.

Collaborators

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.

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

March 1, 2016

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

March 28, 2016

First Submitted That Met QC Criteria

April 4, 2016

First Posted (ESTIMATE)

April 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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