Xingnaojing for Mild-to-severe Acute Ischemic Stroke

Phase 4

• Conditions: Acute Ischemic Stroke; Stroke, Acute; Stroke, Ischemic
• Interventions: Drug: Xingnaojing injection; Drug: Xingnaojing placebo injection; Other: Standard care

• Registration Number: NCT04150835
• Lead Sponsor: Dongzhimen Hospital, Beijing

Brief Summary

The main purpose of this trial is to determine whether Xingnaojing, intravenously administered within 24 hours of symptom onset, improves the daily living ability of acute ischemic stroke at 90 days.

Detailed Description

The XMAS-2 study is a multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary hypothesis of this trial is that Xingnaojing will improve the daily living ability of acute ischemic stroke at 90 days. Xingnaojing will be compared to placebo, combined with guidelines-based standard care in patients with acute ischemic stroke within 24 hours of symptom onset. All participants will have a National Institutes of Health Stroke Scale(NIHSS)entry score of 4-25. Participants who have planned or already received the intravenous thrombolysis or endovascular treatment will be excluded. The primary outcome will be determined at 90 days.

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-05
• Study Start: 2020-03-19
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-04-01
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• Diagnosis of Acute ischemic stroke；
• Symptom onset within 24 hours；
• Age ≥ 18 and ≤ 80 years；
• NIHSS score ≥ 4 and ≤ 25；
• Patient or legally authorized representative has signed informed consent.

Exclusion Criteria

• Planned or already receiving intravenous thrombolysis or endovascular treatment;
• Suspected secondary stroke caused by tumor, brain trauma, or hematological diseases;
• Already dependent in activities of daily living before the present acute stroke (defined as modified Rankin Scale score ≥ 2) ;
• Other conditions that cause cardiogenic embolism (e.g., atrial fibrillation, rheumatic heart disease, valvular heart disease);
• 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 (ALT), or aspartate aminotransferase (AST) value that is twice the upper limit of normal);
• Life expectancy of 3 months 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xingnaojing	Xingnaojing injection	Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Xingnaojing	Standard care	Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.
Placebo	Xingnaojing placebo injection	Subjects will receive intravenously administered Xingnaojing placebo, combined with guidelines-based standard care.
Placebo	Standard care	Subjects will receive intravenously administered Xingnaojing placebo, combined with guidelines-based standard care.

Primary Outcome Measures

Name	Time	Method
The proportion of patients independent.	90 days	Proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2.The Modified Rankin Scale Score ranges from 0 (best score) to 6 (worst score).

Secondary Outcome Measures

Name	Time	Method
The proportion of patients independent at 30 days.	30 days	The proportion of patients independent will be evaluated by mRS at 30 days.The mRS score ranges from 0 (best score) to 6 (worst score).
The recurrence rate of cerebrovascular events	Within 90 days	The recurrence rate of cerebrovascular events within 90 days.
Safety end points	10 days	Number of patients with any adverse events, results of electrocardiography, vital signs and laboratory tests (complete blood count, chemistry and urinalysis).
Early neurological deterioration.	Baseline and 3 days	The early neurologic deterioration is defined as an increase of 1 points or more in the National Institute of Health Stroke Scale (NIHSS) score between baseline and 3 days. The NIHSS score ranges from 0 (best score) to 42 (worst score).
Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS).	Baseline and 10 days	Comparison of the change in the NIHSS scores from baseline to 10 days in the two groups.The NIHSS score ranges from 0 (best score) to 42 (worst score).
Patient reported outcome	10 days	Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 36(best score) to 180 (worst score).
State of consciousness	48 hours and 7 days	The state of consciousness evaluated by Glasgow Coma Scale at 7 days. The Glasgow score ranges from 3(worst score) to 15 (best score).
Activities of daily living	30 days and 90 days	Activities of daily living will be measured by Barthel Index score at 30 days and 90 days.The Barthel Index score ranges from 0 (worst score) to 100 (best score).
Stroke related deaths and deaths from any cause	Within 10 days and 90 days	Stroke related deaths and deaths from any cause within 10 days and 90 days after symptom onset.

Trial Locations

Locations (1)

Dongzhimen Hospital; 🇨🇳 Beijing, Beijing, China