Back to resultsEvaluation of Xueshuantong in Patients With AcutE IschemiC STroke (EXPECT)
Primary Purpose
Acute Ischemic Stroke
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xueshuantong lyophilized powder
Placebo
Guidelines-based standard care
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of acute ischemic stroke.
- Patients that can be treated with study drug within 72 hours of symptoms onset defined by the "last see normal" principle.
- 4 ≤ NIHSS score ≤ 16 (total score of upper and lower limbs on motor deficits ≥ 2) at the randomization time.
- Female or male aged ≥ 18 years and ≤ 80 years.
- Provision of signed informed consent prior to any study-specific procedure.
Exclusion Criteria:
- Patients who have received intravenous/intra-arterial thrombolysis or mechanical thrombectomy prior to randomization.
- Secondary stroke caused by tumor, traumatic brain Injury, hematological disease or other diseases with the explicit diagnosis.
- mRS grade ≥ 2 pre-morbid historical assessment.
- Other conditions that lead to motor dysfunction (e.g. claudication, severe osteoarthrosis, rheumatoid arthritis, gouty arthritis or other diseases).
- Known severe impairment of liver function or renal function.
- Known hypersensitivity to study drugs.
- Known severe comorbidity with life expectancy < 3 months.
- 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.
- Pregnancy or breastfeeding.
- 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).
Sites / Locations
- Dongzhimen HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Xueshuantong
Placebo
Arm Description
Patients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care.
Patients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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).
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).
Incidence of treatment-related adverse events
Number of patients with any adverse events during the study.
Full Information
NCT ID
NCT04415164
First Posted
May 25, 2020
Last Updated
April 8, 2021
Sponsor
Dongzhimen Hospital, Beijing
Collaborators
Tianjin University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04415164
Brief Title
Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke
Acronym
EXPECT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongzhimen Hospital, Beijing
Collaborators
Tianjin University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Xueshuantong
Arm Type
Experimental
Arm Description
Patients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care.
Intervention Type
Drug
Intervention Name(s)
Xueshuantong lyophilized powder
Other Intervention Name(s)
Zhusheyong Xueshuantong (donggan), WS-10460(ZD-0460)-2002-2011Z
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Xueshuantong lyophilized powder Placebo. The usage of placebo is the same as that in the experimental group.
Intervention Type
Other
Intervention Name(s)
Guidelines-based standard care
Intervention Description
Guidelines-based standard care for acute ischemic stroke
Primary Outcome Measure Information:
Title
Change in National Institute of Health Stroke Scale score on day 10 (after the treatment) from baseline
Description
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.
Time Frame
Day 10 ± 2
Secondary Outcome Measure Information:
Title
The proportion of patients with National Institute of Health Stroke Scale score 0-1 on day 10 (after the treatment)
Description
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.
Time Frame
Day 10 ± 2
Title
Patients-reported outcome of patients measured by Patient-Reported Outcomes Scale for Stroke on day 10 (after the treatment)
Description
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).
Time Frame
Day 10 ± 2
Title
The proportion of patients with modified Rankin Scale grade ≤1 on day 90
Description
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.
Time Frame
Day 90 ± 7
Title
The proportion of patients with Barthel Index (BI) score greater than or equal to 90 on day 90
Description
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).
Time Frame
Day 90 ± 7
Title
Quality of life of patients measured by Stroke-specific quality of life scale on day 90
Description
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).
Time Frame
Day 90 ± 7
Title
Incidence of treatment-related adverse events
Description
Number of patients with any adverse events during the study.
Time Frame
Up to Day 90
Other Pre-specified Outcome Measures:
Title
Change in intercellular adhesion molecule 1 level on day 10 (after the treatment) from baseline
Description
Level of intercellular adhesion molecule 1 is associated with the clinical outcome.
Time Frame
Day 10 ± 2
Title
Change in Interleukin 6 level on day 10 (after the treatment) from baseline
Description
Level of Interleukin 6 is associated with the clinical outcome.
Time Frame
Day 10 ± 2
Title
Change in tumor necrosis factor-α level on day 10 (after the treatment) from baseline
Description
Level of tumor necrosis factor-α is associated with the clinical outcome.
Time Frame
Day 10 ± 2
Title
Change in matrix metalloproteinase 9 level on day 10 (after the treatment) from baseline
Description
Level of matrix metalloproteinase 9 is associated with the clinical outcome.
Time Frame
Day 10 ± 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of acute ischemic stroke.
Patients that can be treated with study drug within 72 hours of symptoms onset defined by the "last see normal" principle.
4 ≤ NIHSS score ≤ 16 (total score of upper and lower limbs on motor deficits ≥ 2) at the randomization time.
Female or male aged ≥ 18 years and ≤ 80 years.
Provision of signed informed consent prior to any study-specific procedure.
Exclusion Criteria:
Patients who have received intravenous/intra-arterial thrombolysis or mechanical thrombectomy prior to randomization.
Secondary stroke caused by tumor, traumatic brain Injury, hematological disease or other diseases with the explicit diagnosis.
mRS grade ≥ 2 pre-morbid historical assessment.
Other conditions that lead to motor dysfunction (e.g. claudication, severe osteoarthrosis, rheumatoid arthritis, gouty arthritis or other diseases).
Known severe impairment of liver function or renal function.
Known hypersensitivity to study drugs.
Known severe comorbidity with life expectancy < 3 months.
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.
Pregnancy or breastfeeding.
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Gao
Phone
0086-010-84013209
Email
gaoying973@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luda Feng
Phone
(+86)13051528128
Email
luda_feng@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Gao
Organizational Affiliation
Dongzhimen Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongzhimen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luda Feng
Email
luda_feng@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke
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