Xingnaojing for Mild-to-severe Acute Ischemic Stroke (XMAS-2)

Dongzhimen Hospital, Beijing

Status and phase: Unknown; Phase 4

Conditions: Stroke, Acute; Acute Ischemic Stroke; Stroke, Ischemic

Treatments: Drug: Xingnaojing injection; Other: Standard care; Drug: Xingnaojing placebo injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04150835

2018YFC1705001

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 daily living ability of acute ischemic stroke at 90 days.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,200 participants in 2 patient groups, including a placebo group

Xingnaojing

Experimental group

Description:

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

Treatment:

Drug: Xingnaojing injection

Other: Standard care

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Xingnaojing placebo injection

Other: Standard care