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Real-World Evaluation of Recombinant Human Prourokinase for Acute Ischemic Stroke Within 4.5 Hours

NCT07787325 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2026-08-26

No results posted yet for this study

Summary

Acute ischemic stroke is a major cause of disability and death. Intravenous thrombolytic therapy is an important treatment option when given within the appropriate time window. Recombinant human prourokinase (rhPro-UK) is a thrombolytic medication approved for the treatment of acute ischemic stroke within 4.5 hours after symptom onset in China.

This prospective, multicenter cohort registry study aims to evaluate the effectiveness and safety of intravenous rhPro-UK in patients with acute ischemic stroke treated within 4.5 hours of symptom onset. Approximately 3,000 patients from multiple centers will be enrolled and followed for 90 days. Clinical outcomes, bleeding events, adverse events, and functional recovery will be collected and analyzed to provide further evidence on the use of rhPro-UK in routine clinical practice.

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

Recombinant Human Prourokinase

Intravenous administration of recombinant human prourokinase for acute ischemic stroke within 4.5 hours of symptom onset. The total dose is 35 mg, consisting of a 15 mg intravenous bolus followed by 20 mg continuous infusion over 30 minutes.

Sponsors & Collaborators

  • The First Affiliated Hospital of Anhui Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-11
Primary Completion
2029-08-31
Completion
2029-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07787325 on ClinicalTrials.gov