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NCT07787325

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

Sponsor: The First Affiliated Hospital of Anhui Medical University

View on ClinicalTrials.gov

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.

Official title: A Prospective Multicenter Cohort Registry Study of Intravenous Recombinant Human Prourokinase for Acute Ischemic Stroke Within 4.5 Hours of Symptom Onset (PRISM)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2026-09-11

Completion Date

2029-08-31

Last Updated

2026-08-26

Healthy Volunteers

No

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.

Locations (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China