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NOT YET RECRUITING
NCT07901842
PHASE3

Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence

Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine

View on ClinicalTrials.gov

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.

Official title: Intravenous Recombinant Human Prourokinase for Extended-Window Acute Ischemic Stroke Selected by NCCT-Based Artificial Intelligence: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

826

Start Date

2026-12-01

Completion Date

2030-06-01

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (1)

Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhengjiang, China