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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Xingnaojing and standard care

Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.

Group Type EXPERIMENTAL

Xingnaojing injection

Intervention Type DRUG

Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.

Standard care

Intervention Type OTHER

Guidelines-based standard care for acute ischemic stroke.

Standard care only

Subjects will receive guidelines-based standard care only.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Guidelines-based standard care for acute ischemic stroke.

Interventions

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Xingnaojing injection

Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.

Intervention Type DRUG

Standard care

Guidelines-based standard care for acute ischemic stroke.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No