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.
Adults aged ≥18 years, regardless of sex.
Pre-stroke modified Rankin Scale (mRS) score of 0-1.
Patients with acute ischemic stroke treated within 4.5 hours of symptom onset, who are considered suitable for intravenous thrombolysis with recombinant human prourokinase by the treating investigator.
Written informed consent obtained from the participant or legally authorized representative.
Known severe hypersensitivity to recombinant human prourokinase.
Other severe neurological, psychiatric, or systemic diseases that may interfere with outcome assessment, adherence, or follow-up.
Uncontrolled severe hypertension before treatment (systolic blood pressure ≥185 mmHg or diastolic blood pressure ≥110 mmHg despite antihypertensive therapy).
Blood glucose <2.8 mmol/L or >22.2 mmol/L that remains uncontrolled after correction.
Adults with acute ischemic stroke who receive intravenous recombinant human prourokinase treatment within 4.5 hours of symptom onset. Eligible participants are patients aged ≥18 years with a pre-stroke modified Rankin Scale (mRS) score of 0-1 who are considered suitable for intravenous thrombolysis with recombinant human prourokinase by the treating investigator.
Cohort
Prospective
Recombinant Human Prourokinase
DrugIntravenous 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.
Excellent Functional Outcome at 90 Days
The proportion of participants achieving an excellent functional outcome at 90 days after intravenous recombinant human prourokinase treatment, defined as a modified Rankin Scale (mRS) score of 0-1.
Distribution of Modified Rankin Scale (mRS) Scores at 90 Days
The distribution of modified Rankin Scale (mRS) scores at 90 days after treatment.
Functional Independence at 90 Days
The proportion of participants achieving functional independence at 90 days, defined as a modified Rankin Scale (mRS) score of 0-2.
Barthel Index Score at 90 Days
Barthel Index score assessed at 90 days after treatment.
EQ-5D-5L Score at 90 Days
Health-related quality of life assessed using the EuroQol five-dimensional five-level questionnaire (EQ-5D-5L).
Symptomatic Intracranial Hemorrhage Within 36 Hours
The incidence of symptomatic intracranial hemorrhage within 36 hours after treatment according to the SITS-MOST definition.
Any Intracranial Hemorrhage Within 36 Hours
The incidence of any intracranial hemorrhage within 36 hours after treatment according to Heidelberg bleeding classification criteria.
All-Cause Mortality at 90 Days
All-cause mortality within 90 days after treatment.
Serious Adverse Events Within 90 Days
The incidence of serious adverse events within 90 days after treatment.
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