Acute Ischemic StrokePhase 4EXPECTNCT04415164
Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke
A Phase 4 study testing Xueshuantong lyophilized powder in people with Acute Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Xueshuantong lyophilized powder
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2020to 31 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Luda Feng, luda_feng@hotmail.com
About this study
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
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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Xueshuantong lyophilized powder, Placebo, Guidelines-based standard care
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xueshuantong lyophilized powderDrug
Also called Zhusheyong Xueshuantong (donggan), WS-10460(ZD-0460)-2002-2011Z
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.
PlaceboDrug
Xueshuantong lyophilized powder Placebo. The usage of placebo is the same as that in the experimental group.
Guidelines-based standard careOther
Guidelines-based standard care for acute ischemic stroke
| Study group | Role | What they receive |
|---|---|---|
| Xueshuantong | Experimental | Patients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care. Receives: Drug: Xueshuantong lyophilized powder; Other: Guidelines-based standard care |
| Placebo | Placebo comparator | Patients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care. Receives: Drug: Placebo; Other: Guidelines-based standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 10 ± 2
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Day 90 ± 7
Incidence of treatment-related adverse events
Number of patients with any adverse events during the study.
Measured: Up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start29 Sep 2020
- Primary completion31 Oct 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415164
- Sponsor's protocol ID
- P2019-08-BDY-08-V04
- Acronym
- EXPECT
- Status last verified
- Apr 2021
- First submitted
- 25 May 2020
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04415164
- Acronym / sponsor ID
- EXPECT / P2019-08-BDY-08-V04
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Collaborators
- Tianjin University of Traditional Chinese Medicine
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xueshuantong | Experimental | Drug: Xueshuantong lyophilized powder, Other: Guidelines-based standard carePatients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care. |
| Placebo | Placebo comparator | Drug: Placebo, Other: Guidelines-based standard carePatients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xueshuantong lyophilized powderAlso: Zhusheyong Xueshuantong (donggan), WS-10460(ZD-0460)-2002-2011ZXueshuantong lyophilized powder (500mg), diluted with 250 ml of 0.9% sodium chloride injection, IV (in the vein), once a day, continue for 10 days. | Drug | Xueshuantong |
| PlaceboXueshuantong lyophilized powder Placebo. The usage of placebo is the same as that in the experimental group. | Drug | Placebo |
| Guidelines-based standard careGuidelines-based standard care for acute ischemic stroke | Other | Placebo, Xueshuantong |
Primary outcome
Change in National Institute of Health Stroke Scale score on day 10 (after the treatment) from baseline
Time frame: Day 10 ± 2
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.
6 secondary outcomes
The proportion of patients with National Institute of Health Stroke Scale score 0-1 on day 10 (after the treatment)
Time frame: Day 10 ± 2
Patients-reported outcome of patients measured by Patient-Reported Outcomes Scale for Stroke on day 10 (after the treatment)
Time frame: Day 10 ± 2
The proportion of patients with modified Rankin Scale grade ≤1 on day 90
Time frame: Day 90 ± 7
The proportion of patients with Barthel Index (BI) score greater than or equal to 90 on day 90
Time frame: Day 90 ± 7
Quality of life of patients measured by Stroke-specific quality of life scale on day 90
Time frame: Day 90 ± 7
Incidence of treatment-related adverse events
Time frame: Up to Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Gao principal investigator
Dongzhimen Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xueshuantong lyophilized powder in people with Acute Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Gao (0086-010-84013209, gaoying973@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in National Institute of Health Stroke Scale score on day 10 (after the treatment) from baseline (time frame: Day 10 ± 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.