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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic; Stroke, Acute; Acute Ischemic Stroke
• Intervention / Treatment: Drug: Xingnaojing injection; Other: Standard care; Drug: Xingnaojing placebo injection

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 Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tiantian Meng, MD; Phone Number: (+86)17812171713; Email: 17812171713@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100700
      • Recruiting
      • Dongzhimen Hospital
      • Contact: Tiantian Meng, MD; Phone Number: 0086-17812171713; Email: 17812171713@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xingnaojing; Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care.	Drug: Xingnaojing injection; Xingnaojing 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.
Placebo Comparator: Placebo; Subjects will receive intravenously administered Xingnaojing placebo, combined with guidelines-based standard care.	Other: Standard care; Guidelines-based standard care for acute ischemic stroke.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients independent.	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).	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early neurological deterioration.	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).	Baseline and 3 days
Neurological impairment evaluated by National Institute of Health Stroke Scale (NIHSS).	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).	Baseline and 10 days
Patient reported outcome	Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 36(best score) to 180 (worst score).	10 days
State of consciousness	The state of consciousness evaluated by Glasgow Coma Scale at 7 days. The Glasgow score ranges from 3(worst score) to 15 (best score).	48 hours and 7 days
Activities of daily living	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).	30 days and 90 days
The proportion of patients independent at 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).	30 days
The recurrence rate of cerebrovascular events	The recurrence rate of cerebrovascular events within 90 days.	Within 90 days
Stroke related deaths and deaths from any cause	Stroke related deaths and deaths from any cause within 10 days and 90 days after symptom onset.	Within 10 days and 90 days
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

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing
• Collaborators: The Second Hospital of Hebei Medical University; Peking University Third Hospital; The First Hospital of Jilin University; Second Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; Hubei Hospital of Traditional Chinese Medicine; Yantai Yuhuangding Hospital; People's Hospital of Quzhou; Zhejiang Provincial Hospital of TCM; The Third People's Hospital of Hubei Province; Zhejiang Provincial Tongde Hospital; Shandong University of Traditional Chinese Medicine; Beijing Shuyi Hospital; The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine; Longhua Hospital; The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine; Hunan Academy of Traditional Chinese Medicine Affiliated Hospital; First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; Anshan Central Hospital; Haikou People's Hospital; Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine; The Airport Hospital of Shunyi District Beijing; The NO.4 People's Hospital of Hengshui; The Affiliated Hospital of Shaanxi University of Chinese Medicine; Tianshui Hospital of Traditional Chinese Medicine; The Affiliated Hospital of Changzhi Academy of TCM; Zibo Hospital of Traditional Chinese Medicine; Taizhou Traditional Chinese Medicine Hospital; The First Affiliated Hospital of Guizhou University of TCM; Guangzhou Hospital of Traditional Chinese Medicine; The First Affiliated Hospital of Guangxi University of Chinese Medicine; Liling Hospital of Traditional Chinese Medicine; The First Hospital of Qiqihar City; The Second People's Hospital of Anhui Province; The Third Affiliated Hospital of Shenzhen University; The Third Hospital of Xi'an City

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Double-Blind; Randomized Controlled Trial; Traditional Chinese Medicine; Acute ischemic stroke; Xingnaojing injection
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 2018YFC1705001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No