Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Condition(s) studied
Investigational drug(s) / intervention(s)
Recombinant Human Prourokinase for Injection (rhPro-UK): A total dose of 35 mg will be administered intravenously. The initial 15 mg dissolved in 10 mL solution will be administered by intravenous bolus over 3 minutes, followed by 20 mg dissolved in 90 mL solution administered by intravenous infusion over 30 minutes.
Matching Placebo for Recombinant Human Prourokinase: Matching placebo will be administered intravenously using the same administration volumes, route, and durations as the active study drug to maintain blinding.
Study summary
This multicenter, prospective, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of intravenous recombinant human prourokinase (rhPro-UK) in patients with acute ischemic stroke treated more than 4.5 hours and up to 24 hours after stroke onset, selected using a noncontrast computed tomography-based artificial intelligence (CT-AI) tissue-window algorithm.
A total of 826 participants will be randomly assigned in a 1:1 ratio to receive intravenous rhPro-UK or matching placebo, in addition to guideline-recommended standard stroke care.
The primary outcome is the proportion of participants achieving a modified Rankin Scale (mRS) score of 0-1 at 90 ± 7 days. Secondary outcomes include functional outcomes, changes in neurological deficits, early neurological improvement at 24 hours and 7 days, and tissue reperfusion at 24-48 hours. Safety outcomes include symptomatic intracranial hemorrhage, parenchymal hematoma, all-cause mortality, and serious systemic bleeding.
Eligibility
Primary outcome measure(s)
- Proportion of Participants With a Modified Rankin Scale Score of 0-1 at 90 Days — 90 ± 7 days after randomization
The proportion of participants achieving a modified Rankin Scale (mRS) score of 0 or 1. The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating better functional outcomes.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine | Hangzhou | Zhengjiang |
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07901842 on ClinicalTrials.gov ↗ ← All trials in China