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

Recruiting

Phase 4 Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Standard Care Behavioral
    Intervention Desc: Guidelines-based standard care for acute ischemic stroke.
    ARM 1: Kind: Experimental
    Label: Xingnaojing and standard care
    Description: Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
    ARM 2: Kind: Experimental
    Label: Standard care only
    Description: Subjects will receive guidelines-based standard care only.
  • Xingnaojing injection Drug
    Intervention Desc: Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.
    ARM 1: Kind: Experimental
    Label: Xingnaojing and standard care
    Description: Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients independent 90 days No
Secondary Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups. Baseline and 10 days. No
Secondary Activities of daily living 30 days and 90 days No
Secondary Patient reported outcome (PRO) scale of stroke 10 days No
Secondary Early neurologic deterioration (END) Baseline and 48 hours Yes
Secondary Symptomatic Intracranial Hemorrhage (sICH) 10 dyas Yes
Secondary Deaths from any cause 10 days, 90 days Yes
Secondary Safety end points - Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis). 10 days Yes
Secondary Cardiovascular events 90 days Yes

Sponsors