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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Huashan Hospital
RECRUITING
Shanghai
Contact Information
Primary
Qiang Dong, M.D.
13701747065@163.com
13701747065
Backup
Wenjie Cao, M.D.
wenjiecao@fudan.edu.cn
13918206324
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2025-12
Participants
Target number of participants: 120
Treatments
Experimental: Human Urinary Kallidinogenase
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Stroke Association
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov