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Recruiting NCT06211712

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

No phase Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental: Human Urinary Kallidinogenase, Placebo Comparator: Placebo.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Drug 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.
  • Drug 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Huashan Hospital — Shanghai

Identifiers

NCT: NCT06211712 · KY2023-707

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗