Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xueshuantong

Patients will receive intravenously administered Xueshuantong, combined with guidelines-based standard care.

Group Type EXPERIMENTAL

Xueshuantong lyophilized powder

Intervention Type DRUG

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.

Guidelines-based standard care

Intervention Type OTHER

Guidelines-based standard care for acute ischemic stroke

Placebo

Patients will receive intravenously administered Xueshuantong placebo, combined with guidelines-based standard care.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Xueshuantong lyophilized powder Placebo. The usage of placebo is the same as that in the experimental group.

Guidelines-based standard care

Intervention Type OTHER

Guidelines-based standard care for acute ischemic stroke

Interventions

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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.

Intervention Type DRUG

Placebo

Xueshuantong lyophilized powder Placebo. The usage of placebo is the same as that in the experimental group.

Intervention Type DRUG

Guidelines-based standard care

Guidelines-based standard care for acute ischemic stroke

Intervention Type OTHER

Other Intervention Names

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Zhusheyong Xueshuantong (donggan) WS-10460(ZD-0460)-2002-2011Z

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No