Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongzhimen Hospital, Beijing
• Collaborator: Tianjin University of Traditional Chinese Medicine

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).