Status:
UNKNOWN
Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke
Lead Sponsor:
Dongzhimen Hospital, Beijing
Collaborating Sponsors:
Tianjin University of Traditional Chinese Medicine
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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
- 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
- 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).
Key Trial Info
Start Date :
September 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04415164
Start Date
September 29 2020
End Date
May 31 2023
Last Update
April 9 2021
Active Locations (1)
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1
Dongzhimen Hospital
Beijing, Beijing Municipality, China, 100700