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

Acute Ischemic Stroke Clinical Trial

— HEAL  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06211712
• Other study ID #: KY2023-707
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Huashan Hospital
• Contact: Qiang Dong, M.D.
• Phone: 13701747065
• Email: 13701747065[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 days. The safety of Human Urinary Kallidinogenase will be evaluated through 90 days. End of study evaluation will occur at day 90 or premature discontinuation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Participant with acute anterior circulation ischemic stroke receiving endovascular treatment within 24 hours (non-bridged).

2. Age =18 years old and =80 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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Huashan Hospital	Shanghai Stroke Association

Outcome

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