Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke

NCT04415164 | Unknown Phase 4 DMC

• 1 other identifier: P2019-08-BDY-08-V04
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The proportion of patients with National Institute of Health Stroke Scale score 0-1 on day 10 (after the treatment)

  Day 10 ± 2

• Patients-reported outcome of patients measured by Patient-Reported Outcomes Scale for Stroke on day 10 (after the treatment)

  Day 10 ± 2

• The proportion of patients with modified Rankin Scale grade ≤1 on day 90

  Day 90 ± 7

• The proportion of patients with Barthel Index (BI) score greater than or equal to 90 on day 90

  Day 90 ± 7

• Quality of life of patients measured by Stroke-specific quality of life scale on day 90

  Day 90 ± 7

Other Outcomes (4)

• Change in intercellular adhesion molecule 1 level on day 10 (after the treatment) from baseline

  Day 10 ± 2

• Change in Interleukin 6 level on day 10 (after the treatment) from baseline

  Day 10 ± 2

• Change in tumor necrosis factor-α level on day 10 (after the treatment) from baseline

  Day 10 ± 2

Study Arms (2)

Xueshuantong

EXPERIMENTAL

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

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.

Drug: Placebo; Other: Guidelines-based standard care

Interventions

Xueshuantong lyophilized powder 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.

Also known as: Zhusheyong Xueshuantong (donggan), WS-10460(ZD-0460)-2002-2011Z

Xueshuantong

Placebo DRUG

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

Placebo

Guidelines-based standard care OTHER

Guidelines-based standard care for acute ischemic stroke

Placebo; Xueshuantong

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ≤ 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead
• Tianjin University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Dongzhimen Hospital

Beijing, Beijing Municipality, 100700, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ying Gao

  Dongzhimen Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Gao

CONTACT

0086-010-84013209; gaoying973@126.com

Luda Feng

CONTACT

(+86)13051528128; luda_feng@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Institute for Brain Disorders, Beijing University of Chinese Medicine

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 4, 2020
• Study Start: September 29, 2020
• Primary Completion: October 31, 2022
• Study Completion: May 31, 2023
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)