NCT06085378

Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus

Efficacy and Safety of Urinary Kallidinogenase in the Treatment of Acute Ischemic Stroke Combined With Type 2 Diabetes Mellitus (TK-SEEK): a Prospective, Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 630 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, placebo parallel control study, aim to evaluate the efficacy and safety of human urinary kallidinogenase in the treatment of acute ischemic stroke with type 2 diabetes.

Detailed description

The study process lasts for a total of 90 days, including the screening period, intervention period, and follow-up period. During the intervention period, the experimental group is treated with Urinary Kallidinogenase, while the control group is treated with placebo for 10 days. Both groups receive routine clinical treatment. All patients are followed up until the 90th day after stroke. The sample size of the study is 630 patients. The ratio of the experimental group to the control group is 1:1.

Conditions

• Acute Ischemic Stroke
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Urinary Kallidinogenase for injection	The 0.15 peptide nucleic acids(PNA) unit of Eurecrine for injection was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. The solvent can be increased and/or slowed down according to the patient's condition for 10 consecutive days, while receiving clinical routine treatment for 10 days
OTHER	Placebo	The 0.15 peptide nucleic acids(PNA) unit of placebo was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day. The solvent can be increased and/or slowed down according to the patient's condition for 10 consecutive days, while receiving clinical routine treatment for 10 days.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-10-16
• Last updated: 2023-10-16

Locations

1 site across 1 country: China