NCT06848894

Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,204 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the efficacy and safety of Human Urinary Kallidinogenase for acute ischemic stroke patients receiving intravenous thrombolysis and/or endovascular treatment.

Detailed description

Within 24 hours after symptom onset, eligible participants will be randomly assigned in a 1:1 ratio to the HUK or placebo group, receiving adjunctive HUK or placebo treatment alongside standard intravenous thrombolysis and/or endovascular treatment. All participants will be recommended to continuously inject drugs or placebo for 10 to 14 days according to length of hospitalization. * Intervention group: HUK (0.15 PNA) and sodium chloride injection (100ml), once per day * Control group: placebo (0 PNA) and sodium chloride injection (100ml), once per day The total follow-up duration is 90 days.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Human urinary kallidinogenase (HUK)	HUK (0.15 PNA) and sodium chloride injection (100ml), once per day
DRUG	Placebo	placebo (0 PNA) and sodium chloride injection (100ml), once per day

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-02-27
• Last updated: 2025-03-28

Locations

1 site across 1 country: China