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

NCT06211712 | Recruiting

• 1 other identifier: KY2023-707
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• ASPECT score evaluated using routine CT

  on day 7 after EVT

• Modified Rankin Scale (mRS) score

  on day 90 after EVT

Secondary Outcomes (7)

• Barthel index

  on day 10 and 90 after EVT

• Percentage of TIC ≥ 2b and mRS ≤2

  on day 90 after EVT

• 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

• Changes of blood inflammatory index and vascular endothelial cell growth index from day 1 after EVT

  day 7 after EVT

Study Arms (2)

Human Urinary Kallidinogenase

EXPERIMENTAL

Drug: Experimental: Human Urinary Kallidinogenase

Placebo

PLACEBO COMPARATOR

Drug: Placebo Comparator: Placebo

Interventions

Experimental: Human Urinary Kallidinogenase DRUG

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.

Human Urinary Kallidinogenase

Placebo Comparator: Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai Stroke Association: collaborator

Study Sites (1)

Huashan Hospital

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Qiang Dong, M.D.

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Wenjie Cao, M.D.

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Dong, M.D.

CONTACT

13701747065; 13701747065@163.com

Wenjie Cao, M.D.

CONTACT

13918206324; wenjiecao@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Model Details: A randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 18, 2024
• Study Start: April 17, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Locations

CN (1)