NCT06132880

Effects of Human Urinary Kallidinogenase on Early Improvement and Functional Outcomes in Acute Ischemic Stroke (TK-SPEED)

Effects of Human Urinary Kallidinogenase on Early Improvement and Functional Outcomes in Acute Ischemic Stroke: a Multicenter, Randomized, Open Label, Blinded-endpoint, Controlled Study (TK-SPEED)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this trial is to evaluate the effects of Human Urinary Kallidinogenase on improvement of neurological outcome, and early cerebral perfusion in acute ischemic stroke.

Detailed description

This is a multicentre, randomized, open label, blinded-endpoint trial that aims to investigate the effects of Human Urinary Kallidinogenase treatment on neurological outcomes, early cerebral perfusion in patients with acute anterior circulation ischemic stroke. Patients in intervention group will be given 0.15 peptide nucleic acids (PNA) Human Urinary Kallidinogenase concentrated solution for intravenous injection once a day for 10 days continuously, and those in the control group will be given conventional therapy. Both groups of patients will be on standard stroke care. In this study, patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio after the informed consent form (ICF) was received. The total sample size will be 540. All patients will be followed up for 90 days. The primary outcome is the proportion of modified Rankin Scale 0-2. Besides, the investigators aimed to use computed tomography perfusion (CTP) evaluate the differences of ischemic penumbra volume and regional cerebral blood flow (rCBF) before and after treatment between intervention group and control group. Furthermore, this study adopts adaptive design, prospectively stating interim analyses with specified stopping rules, which allow for the possibility of the study to terminate early based on either determination of study success or of the futility to continue further enrollment.

Conditions

• Acute Ischemic Stroke
• Functional Outcomes

Interventions

Type	Name	Description
DRUG	Human Urinary Kallidinogenase	Intravenous injections of urinary kallidinogenase (0.15 peptide nucleic acids (PNA) in 0.9% NaCl) intravenous drip QD for 10 days.
OTHER	Clinical Routine Treatment	Conventional therapy of acute ischemic stroke after based on Chinese guidelines

Timeline

• Start date: 2023-12-14
• Primary completion: 2026-08-28
• Completion: 2026-12-31
• First posted: 2023-11-15
• Last updated: 2023-12-06