Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke

Analysing the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke(AXAIS): A Multicenter, Randomized, Open-label, Controlled Trial

The main purpose of this trial is to analyse the Effects of Xingnaojing for Mild-to-severe Acute Ischemic Stroke by Metabonomics, proteomics and clinical parameters.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Acute Stroke
• Intervention / Treatment: Drug: Xingnaojing injection

Detailed Description

Xingnaojing is widely used in China, but there is lack of sufficient and reasonable explanation of its intervention effects for acute ischemic stroke currently. The primary hypothesis of this trial is that , Compared with the blank control group, Xingnaojing will produce serial changes in plasma and urine metabolites and biomarkers at baseline (pre-dose), 8 days and 11days . The serial changes may be the potential support to explain the intervention effect of Xingnaojing. 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 11 days.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100700
      • Recruiting
      • Dongzhimen Hospital
      • Contact: Ping Jiang, MD; Phone Number: 0086-18810923089; Email: 18810923089@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Expected length of hospital stay is less than 10 days;
• Planned or already receiving intravenous thrombolysis or endovascular treatment;
• Use of drugs with unknown composition within 1 week before enrollment;
• Patients with acute infectious diseases (e.g. acute pneumonia) or taking related drugs within 1 month before treatment in the group;
• 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: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xingnaojing injection; Subjects will receive intravenously administered Xingnaojing injection, combined with guidelines-based standard care. Interventions: Drug: Xingnaojing injection Other: 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.
No Intervention: Standard care; Subjects will receive guidelines-based standard care. Interventions: Other: Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of NIHSS score	The NIHSS score ranges from 0 (best score) to 42 (worst score).	Baseline, 3 days, 7 days and 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
The proportion of NIHSS score from 0 to 1	The NIHSS score ranges from 0 (best score) to 42 (worst score).	Baseline, 3 days, 7 days and 10 days
Patient reported outcome (PRO) scale of stroke	Patient reported outcome (PRO) scale of stroke at 10 days.The PRO score ranges from 0(worst score) to 180 (best score).	10 days
The proportion of patients independent at 30 days and 90 days	The proportion of patients independent is defined as Modified Rankin Scale score of 0, 1, or 2. The mRS score ranges from 0 (best score) to 6 (worst score).	30 days and 90 days
Cardio-cerebral vascular incident	Cardio-cerebral vascular incident were defined as stroke, acute coronary syndrome (acute ST-elevation myocardial infarction, acute non-ST-elevation myocardial infarction and unstable angina), vascular death, etc.	Within baseline and 90 days
The difference in proteomic and metabolomics	Through proteomics and metabonomics to explore whether there are different metabolites or proteins between the two groups.（It's not known whether there are differences in the human body between the two groups.We are in the exploratory stage.）	baseline (pre-dose), 7 days and 11days
State of consciousness	The state of consciousness evaluated by Glasgow Coma Scale at Baseline, 3 days, 7 days and 10 days. The Glasgow score ranges from 3(worst score) to 15 (best score).	Baseline, 3 days, 7 days and 10 days

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing
• Collaborators: Affiliated Hospital of Nantong University; Affiliated Hospital of Chengde Medical University; Nanjing Brian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Anticipated): June 28, 2022
• Study Completion (Anticipated): September 28, 2022

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 21, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• 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: 2018YFC1705001-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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