Trial | NCT04150835  Report issue

Title

Xingnaojing for Mild-to-severe Acute Ischemic Stroke
Xingnaojing for Mild-to-severe Acute Ischemic Stroke (XMAS-2): A Multicenter, Randomized, Double-blind, Placebo-Controlled Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    1200
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.
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 Started
Mar 19
2020
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Apr 01
2021

Drug Xingnaojing injection

Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.

Drug Xingnaojing placebo injection

Xingnaojing placebo injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.

Other Standard care

Guidelines-based standard care for acute ischemic stroke.

Xingnaojing Experimental

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

Placebo Placebo Comparator

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

Criteria 

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;
No Results Posted