Clinical trial NCT04415164: Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Tianjin University of Traditional Chinese Medicine
First posted: 2020-06-04
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in National Institute of Health Stroke Scale score on day 10 (after the treatment) from baseline
timeFrame: Day 10 ± 2
Secondary outcomes:
measure: The proportion of patients with National Institute of Health Stroke Scale score 0-1 on day 10 (after the treatment)
timeFrame: Day 10 ± 2
measure: Patients-reported outcome of patients measured by Patient-Reported Outcomes Scale for Stroke on day 10 (after the treatment)
timeFrame: Day 10 ± 2
measure: The proportion of patients with modified Rankin Scale grade ≤1 on day 90
timeFrame: Day 90 ± 7
measure: The proportion of patients with Barthel Index (BI) score greater than or equal to 90 on day 90
timeFrame: Day 90 ± 7
measure: Quality of life of patients measured by Stroke-specific quality of life scale on day 90
timeFrame: Day 90 ± 7
measure: Incidence of treatment-related adverse events
timeFrame: Up to Day 90
Other outcomes:
measure: Change in intercellular adhesion molecule 1 level on day 10 (after the treatment) from baseline
timeFrame: Day 10 ± 2
measure: Change in Interleukin 6 level on day 10 (after the treatment) from baseline
timeFrame: Day 10 ± 2
measure: Change in tumor necrosis factor-α level on day 10 (after the treatment) from baseline
timeFrame: Day 10 ± 2
measure: Change in matrix metalloproteinase 9 level on day 10 (after the treatment) from baseline
timeFrame: Day 10 ± 2
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
Study officials:
affiliation: Dongzhimen Hospital, Beijing
name: Ying Gao
role: PRINCIPAL_INVESTIGATOR
References: