Why the study?
The specific effects of human urinary kallidinogenase on early cerebral perfusion and its correlation with functional outcomes in acute ischaemic stroke remain incompletely elucidated.
Does human urinary kallidinogenase added to standard therapy improve functional outcomes at 90 days in patients with acute anterior circulation ischaemic stroke?
Population
Approximately 540 participants with acute anterior circulation ischaemic stroke across China
Comparison
HUK plus standard therapy vs standard therapy
Design
Multicentre, prospective, randomised, open-label, blinded-endpoint controlled trial
Follow-up
Day 90
Key result
This protocol describes a randomized controlled trial to evaluate whether human urinary kallidinogenase improves 90-day functional outcomes in patients with acute anterior circulation ischemic stroke.
Authors
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Expands options for reperfusion-ineligible acute ischaemic stroke; extends RCT evidence on functional and perfusion outcomes with kallidinogenase.
RCT (n=540)
Open-label, blinded-endpoint
1:1
Yes
Does human urinary kallidinogenase added to standard therapy improve functional outcomes at 90 days in patients with acute anterior circulation ischaemic stroke?
This trial protocol describes a study to determine if human urinary kallidinogenase improves early cerebral perfusion and 90-day functional outcomes in acute ischemic stroke.
Song et al. (2026) conducted an RCT in Acute anterior circulation ischaemic stroke (n=540). Human urinary kallidinogenase (HUK) vs. Standard therapy was evaluated on Proportion of patients with a modified Rankin Scale (mRS) of 0–2 at day 90. This protocol describes a randomized controlled trial to evaluate whether human urinary kallidinogenase improves 90-day functional outcomes in patients with acute anterior circulation ischemic stroke.