Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion

Официальное название

Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Experimental: 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.
• Препарат Placebo Comparator: Placebo
  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.

Первичные конечные точки

• ASPECT score evaluated using routine CT [Срок оценки: on day 7 after EVT]
• Modified Rankin Scale (mRS) score [Срок оценки: on day 90 after EVT]

Вторичные конечные точки (7)

• Barthel index [Срок оценки: on day 10 and 90 after EVT]
• Percentage of TIC ≥ 2b and mRS ≤2 [Срок оценки: on day 90 after EVT]
• Changes of NIH Stroke Scale(NIHSS) score from baseline [Срок оценки: day 1, 4, 7 and 10 after EVT]
• Changes of vital signs from baseline [Срок оценки: day 1, 4, 7 and 10 after EVT]
• Changes of blood inflammatory index and vascular endothelial cell growth index from day 1 after EVT [Срок оценки: day 7 after EVT]
• MRI and / or DWI examined [Срок оценки: within 10 days to determine the infarct volume]
• Recurrence rate of ischemic stroke [Срок оценки: within 90 days after EVT]

Критерии участия

Критерии включения

• Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).
• Age ≥18 years old.
• The mRS score was 0-1 before onset.
• ASPECT score of infarction on emergency CT ≥7.
• Emergency CTA indicating AIS with large vessel occlusion (internal carotid artery, M1 or M2 segment of middle cerebral artery).
• Emergency CTP or DWI suggesting infarct core body ≥10 mL and <100 mL, and low perfusion brain tissue volume/ infarct core volume> 1.2.
• Participant is willing and able to comply with the study protocol, and sign the informed consent form (patient or surrogate).

Критерии исключения

• Participant with severe heart, liver and kidney dysfunction, coagulation dysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrast agent allergy or other angiographic contraindications.
• CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.).
• Participant with previous cerebral hemorrhage, brain tumor, brain trauma or other brain diseases.
• Taking ACEI antihypertensive drugs regularly and could not stop.
• Participant with major surgery or severe trauma in the past 2 weeks.
• Poor compliance and cannot fully follow the study protocol.
• Pregnancy or lactation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Huashan Hospital — Шанхай

Идентификаторы

NCT: NCT06211712 · KY2023-707

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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