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

Dongzhimen Hospital, Beijing

Status and phase: Unknown; Phase 4

Conditions: Acute Ischemic Stroke

Treatments: Other: Standard care; Drug: Xingnaojing injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02728180

2014BAI10B05-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 720 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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720 participants in 2 patient groups

Xingnaojing and standard care

Experimental group

Description:

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

Treatment:

Drug: Xingnaojing injection

Other: Standard care

Standard care only

Active Comparator group

Description:

Subjects will receive guidelines-based standard care only.

Treatment:

Other: Standard care