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September 10, 2026Stroke and Vascular NeurologyOpen Access

Human urinary kallidinogenase trial protocol evaluates 90-day functional outcomes in acute anterior circulation ischemic stroke.

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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

XSXiaowei SongZQZhongqi QiCGCeshu Gao

Discussion

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Overview

Expands options for reperfusion-ineligible acute ischaemic stroke; extends RCT evidence on functional and perfusion outcomes with kallidinogenase.

Key Points

  • To evaluate the efficacy of human urinary kallidinogenase in improving early cerebral blood flow and 90-day functional recovery in patients with acute anterior circulation ischaemic stroke.
  • Multicentre, prospective, randomised, open-label, blinded-endpoint trial (NCT06132880) enrolling approximately 540 patients across roughly 20 centres in China.
  • Participants are randomly assigned 1:1 to receive either human urinary kallidinogenase alongside standard medical therapy or standard therapy alone.
  • The primary efficacy outcome is the proportion of participants achieving functional independence, defined as a modified Rankin Scale score of 0–2 at 90 days post-stroke.
  • Secondary endpoints evaluate early cerebral haemodynamics on CT perfusion (Tmax > 6 s volume and regional cerebral blood flow at day 5) and neurological changes on the National Institutes of Health Stroke Scale at days 5 and 10.

Study Design

Type

RCT (n=540)

Blinding

Open-label, blinded-endpoint

Randomization

1:1

Multicenter

Yes

Structured PICO

Does human urinary kallidinogenase added to standard therapy improve functional outcomes at 90 days in patients with acute anterior circulation ischaemic stroke?

P
Population
Approximately 540 patients with acute anterior circulation ischaemic stroke across China, followed for 90 days.
I
Intervention
Human urinary kallidinogenase (HUK) plus standard therapy
C
Comparator
Standard therapy
O
Outcome
Proportion of patients with a modified Rankin Scale (mRS) of 0–2 at day 90hard clinical

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.

Cite This Study

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.

synapsesocial.com/papers/6aa27c3058559d80afc75e04https://doi.org/10.1136/svn-2026-005582
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