Acute Ischemic Stroke
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Human Urinary Kallidinogenase combined with endovascular therapy in acute ischemic stroke (AIS) patients with large vessel occlusion.
Detailed description
A prospective, randomized, double-blind, placebo-controlled, multi-center study of Human Urinary Kallidinogenase or Placebo, combined with endovascular therapy for AIS patients with large vessel occlusion. Approximately 120 eligible subjects will be randomized (1:1) to receive one of the following treatments for 10 days: * Human Urinary Kallidinogenase combined with endovascular therapy (non-bridged) * Placebo combined with endovascular therapy (non-bridged) Primary efficacy of Human Urinary Kallidinogenase will be evaluated at 90±7 days. The safety of Human Urinary Kallidinogenase will be evaluated through 90±7 days. End of study evaluation will occur at day 90±7 or premature discontinuation.
Interventions
DRUGExperimental: Human Urinary Kallidinogenase
Before the first day of endovascular therapy (non-bridging), dissolve Human Urinary Kallidinogenase in 100 mL 0.9% sodium chloride for intravenous injection, for the next 9 days, once a day for a total of 10 days.
Before the first day of endovascular therapy (non-bridging), dissolve placebo in 100 mL 0.9% sodium chloride for intravenous injection, for the next 9 days, once a day for a total of 10 days.
Sponsors
Shanghai Stroke Association
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
A randomized, double-blind, placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged). 2. Age ≥18 years old. 3. The mRS score was 0-1 before onset. 4. ASPECT score of infarction on emergency CT ≥7. 5. Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery). 6. Emergency CTP or DWI suggesting infarct core body ≥10 mL and \<100 mL, and low perfusion brain tissue volume/ infarct core volume\> 1.2. 7. Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate).
Exclusion criteria
1. Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications. 2. CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.). 3. Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases. 4. Taking ACEI antihypertensive drugs regularly and could not stop. 5. Participant with major surgery or severe trauma in the past 2 weeks. 6. Poor compliance and cannot fully follow the study protocol. 7. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASPECT score evaluated using routine CT | on day 7 after EVT |
| Modified Rankin Scale (mRS) score | on day 90 after EVT |
Secondary
| Measure | Time frame |
|---|---|
| Changes of NIH Stroke Scale(NIHSS) score from baseline | day 1, 4, 7 and 10 after EVT |
| Changes of vital signs from baseline | day 1, 4, 7 and 10 after EVT |
| Barthel index | on day 10 and 90 after EVT |
| MRI and / or DWI examined | within 10 days to determine the infarct volume |
| Recurrence rate of ischemic stroke | within 90 days after EVT |
| Changes of blood inflammatory index and vascular endothelial cell growth index from day 1 after EVT | day 7 after EVT |
| Percentage of TIC ≥ 2b and mRS ≤2 | on day 90 after EVT |
Countries
China
Contacts
Primary ContactQiang Dong, M.D.
Backup ContactWenjie Cao, M.D.
Outcome results
None listed