NCT02728180

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 720 (estimated)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Xingnaojing injection	Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.
OTHER	Standard care	Guidelines-based standard care for acute ischemic stroke.

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2016-04-05
• Last updated: 2019-10-04

Locations

1 site across 1 country: China