Efficacy and Safety of Human Urinary Kallidinogenase Comb... | NCT06211712

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2024Actual

Primary Completion Date

Jun 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Dec 28, 2023

First Submission Date that Met QC Criteria

Jan 9, 2024

First Posted Date

Jan 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2024

Last Update Posted Date

Dec 4, 2024Actual

Name	Class
Shanghai Stroke Association	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Human Urinary Kallidinogenase	Experimental		Drug: Experimental: Human Urinary Kallidinogenase
Placebo	Placebo Comparator		Drug: Placebo Comparator: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ASPECT score evaluated using routine CT		on day 7 after EVT
Modified Rankin Scale (mRS) score		on day 90 after EVT

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qiang Dong, M.D.	Contact	13701747065		13701747065@163.com
Wenjie Cao, M.D.	Contact	13918206324		wenjiecao@fudan.edu.cn

Overall Officials

Name	Affiliation	Role
Qiang Dong, M.D.	Huashan Hospital	Principal Investigator
Wenjie Cao, M.D.	Huashan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huashan Hospital	Recruiting	Shanghai		200040	China

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases