NCT06211712

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2024-04-17
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2024-01-18
• Last updated: 2024-12-04

Locations

1 site across 1 country: China