Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke (EXPECT)

Dongzhimen Hospital, Beijing

Status and phase: Unknown; Phase 4

Conditions: Acute Ischemic Stroke

Treatments: Other: Guidelines-based standard care; Drug: Xueshuantong lyophilized powder; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04415164

P2019-08-BDY-08-V04

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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480 participants in 2 patient groups, including a placebo group

Xueshuantong

Experimental group

Description:

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

Treatment:

Other: Guidelines-based standard care

Drug: Xueshuantong lyophilized powder

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Guidelines-based standard care

Drug: Placebo