A Phase 3 interventional study of Recombinant Human Prourokinase for Injection (rhPro-UK) and Matching Placebo for Recombinant Human Prourokinase in Acute Ischemic Stroke, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 3, Interventional, and Treatment
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.
2,679 studies on the registry are indexed under Ischemic Stroke; 959 are open to participants now.
This study's planned enrollment of 826 is above the median of 120 across 1,818 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 97 studies on the registry; 65 are open to participants now.
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Meeting the CT-AI tissue-window selection criteria:
Exclusion Criteria
Contraindications specified in the prescribing information for recombinant human prourokinase for injection or current intravenous thrombolysis guidelines, other than the extended treatment time window specifically evaluated in this trial, including but not limited to:
Participants will receive intravenous recombinant human prourokinase (rhPro-UK), 35 mg, in addition to guideline-recommended standard stroke care.
Drug: Recombinant Human Prourokinase for Injection (rhPro-UK)
Participants will receive matching intravenous placebo in addition to the same guideline-recommended standard stroke care.
Drug: Matching Placebo for Recombinant Human Prourokinase
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 will be administered intravenously using the same administration volumes, route, and durations as the active study drug to maintain blinding.
Proportion of Participants With a Modified Rankin Scale Score of 0-1 at 90 Days
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.
Time frame: 90 ± 7 days after randomization
Ordinal Distribution of Modified Rankin Scale Scores at 90 Days
The distribution of modified Rankin Scale (mRS) scores from 0 (no symptoms) to 6 (death), with higher scores indicating worse functional outcomes.
Time frame: 90 ± 7 days after randomization
Proportion of Participants With a Modified Rankin Scale Score of 0-2 at 90 Days
The proportion of participants achieving an mRS score of 0-2. The mRS ranges from 0 (no symptoms) to 6 (death).
Time frame: 90 ± 7 days after randomization
Proportion of Participants With a Modified Rankin Scale Score of 0-3 at 90 Days
The proportion of participants achieving an mRS score of 0-3. The mRS ranges from 0 (no symptoms) to 6 (death).
Time frame: 90 ± 7 days after randomization
Change in National Institutes of Health Stroke Scale Score From Baseline to 24 Hours
Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours. The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological impairment.
Time frame: Baseline and 24 hours after randomization
Change in National Institutes of Health Stroke Scale Score From Baseline to Day 7
Change in NIHSS score from baseline to day 7. The NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological impairment.
Time frame: Baseline and 7 days after randomization
Proportion of Participants With Early Neurological Improvement at 24 Hours
The proportion of participants whose NIHSS score decreases by at least 4 points from baseline or reaches 0-1 at 24 hours.
Time frame: 24 hours after randomization
Incidence of Symptomatic Intracranial Hemorrhage Within 36 Hours
The proportion of participants experiencing symptomatic intracranial hemorrhage (sICH), assessed according to ECASS III criteria.
Time frame: Within 36 hours after randomization
Incidence of Parenchymal Hematoma Within 36 Hours
The proportion of participants with parenchymal hematoma (PH), assessed according to ECASS imaging classification.
Time frame: Within 36 hours after randomization
All-Cause Mortality at 90 Days
The proportion of participants who die from any cause during the 90-day follow-up period.
Time frame: 90 ± 7 days after randomization
Other open studies at Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Second Affiliated Hospital, Zhejiang University, School of Medicine