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

Last updated: December 1, 2024
Sponsor: Huashan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Clots

Thrombosis

Cerebral Ischemia

Treatment

Placebo Comparator: Placebo

Experimental: Human Urinary Kallidinogenase

Clinical Study ID

NCT06211712
KY2023-707
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant with acute anterior circulation ischemic stroke receiving endovasculartreatment 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 lowperfusion brain tissue volume/ infarct core volume> 1.2.

  7. Participant is willing and able to comply with the study protocol, and sign theinformed consent form (patient or surrogate).

Exclusion

Exclusion Criteria:

  1. Participant with severe heart, liver and kidney dysfunction, coagulationdysfunction, intolerance to surgery, Human Urinary Kallidinogenase allergy, contrastagent allergy or other angiographic contraindications.

  2. CT or MRI showed intracranial hemorrhagic diseases (such as hemorrhagic stroke,epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoidhemorrhage, etc.).

  3. Participant with previous cerebral hemorrhage, brain tumor, brain trauma or otherbrain 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.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo Comparator: Placebo
Phase:
Study Start date:
April 17, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Huashan Hospital

    Shanghai, 200040
    China

    Active - Recruiting

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