Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke (EXPECT)

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Xueshuantong Lyophilized Powder in Chinese Patients With Acute Ischemic Stroke

The aim is to assess the effects and harms of Xueshuantong lyophilized powder versus placebo in patients with acute ischemic stroke when initiated within 72 hours of symptom onset.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Xueshuantong lyophilized powder; Other: Guidelines-based standard care; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ying Gao; Phone Number: 0086-010-84013209; Email: gaoying973@126.com
• Study Contact Backup: Name: Luda Feng; Phone Number: (+86)13051528128; Email: luda_feng@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100700
      • Recruiting
      • Dongzhimen Hospital
      • Contact: Luda Feng; Email: luda_feng@hotmail.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:

1. Diagnosis of acute ischemic stroke.
2. Patients that can be treated with study drug within 72 hours of symptoms onset defined by the "last see normal" principle.
3. 4 ≤ NIHSS score ≤ 16 (total score of upper and lower limbs on motor deficits ≥ 2) at the randomization time.
4. Female or male aged ≥ 18 years and ≤ 80 years.
5. Provision of signed informed consent prior to any study-specific procedure.

Exclusion Criteria:

1. Patients who have received intravenous/intra-arterial thrombolysis or mechanical thrombectomy prior to randomization.
2. Secondary stroke caused by tumor, traumatic brain Injury, hematological disease or other diseases with the explicit diagnosis.
3. mRS grade ≥ 2 pre-morbid historical assessment.
4. Other conditions that lead to motor dysfunction (e.g. claudication, severe osteoarthrosis, rheumatoid arthritis, gouty arthritis or other diseases).
5. Known severe impairment of liver function or renal function.
6. Known hypersensitivity to study drugs.
7. Known severe comorbidity with life expectancy < 3 months.
8. Known massive cerebral infarction combined with disturbance of consciousness (1a ≥ 2 in NIHSS), dementia, mental impairment, or unsuitable for participation, in the opinion of the investigator.
9. Pregnancy or breastfeeding.
10. Participation in another clinical study with an investigational product at any time during the 3 months prior to randomization (regardless of when treatment with the investigational product was discontinued).

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: Xueshuantong; Patients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care.	Drug: Xueshuantong lyophilized powder; Xueshuantong lyophilized powder (500mg), diluted with 250 ml of 0.9% sodium chloride injection, IV (in the vein), once a day, continue for 10 days.; Other Names: Zhusheyong Xueshuantong (donggan); WS-10460(ZD-0460)-2002-2011Z; Other: Guidelines-based standard care; Guidelines-based standard care for acute ischemic stroke
Placebo Comparator: Placebo; Patients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care.	Other: Guidelines-based standard care; Guidelines-based standard care for acute ischemic stroke; Drug: Placebo; Xueshuantong lyophilized powder Placebo. The usage of placebo is the same as that in the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in National Institute of Health Stroke Scale score on day 10 (after the treatment) from baseline	The aim is to assess the effects of Xueshuantong lyophilized powder versus placebo on reducing the neurological impairment when initiated within 72 hours of symptom onset in patients with acute ischemic stroke. The National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.	Day 10 ± 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with National Institute of Health Stroke Scale score 0-1 on day 10 (after the treatment)	The National Institute of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.	Day 10 ± 2
Patients-reported outcome of patients measured by Patient-Reported Outcomes Scale for Stroke on day 10 (after the treatment)	Patient-Reported Outcomes Scale for Stroke, a structured questionnaire-scale was developed suitable for Chinese patients. The score ranges from 0 (best) to 144 (worst).	Day 10 ± 2
The proportion of patients with modified Rankin Scale grade ≤1 on day 90	Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS grade between 3 to 6 points are considered to be poor functional outcome.	Day 90 ± 7
The proportion of patients with Barthel Index (BI) score greater than or equal to 90 on day 90	Barthel Index is a commonly used scale for measuring the activity of daily living of people. Score of 10-item scale ranges from 0 (worst) to 100 (best).	Day 90 ± 7
Quality of life of patients measured by Stroke-specific quality of life scale on day 90	Stroke-Specific Quality of Life Scale is a standardized instrument for evaluating health-related quality of life. The score of 49-item scale with 12 domains range from 49 (worst) to 245 (best).	Day 90 ± 7
Incidence of treatment-related adverse events	Number of patients with any adverse events during the study.	Up to Day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intercellular adhesion molecule 1 level on day 10 (after the treatment) from baseline	Level of intercellular adhesion molecule 1 is associated with the clinical outcome.	Day 10 ± 2
Change in Interleukin 6 level on day 10 (after the treatment) from baseline	Level of Interleukin 6 is associated with the clinical outcome.	Day 10 ± 2
Change in tumor necrosis factor-α level on day 10 (after the treatment) from baseline	Level of tumor necrosis factor-α is associated with the clinical outcome.	Day 10 ± 2
Change in matrix metalloproteinase 9 level on day 10 (after the treatment) from baseline	Level of matrix metalloproteinase 9 is associated with the clinical outcome.	Day 10 ± 2

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing
• Collaborators: Tianjin University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Ying Gao, Dongzhimen Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: May 30, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

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: P2019-08-BDY-08-V04

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