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.
Study Type
OBSERVATIONAL
Enrollment
3,000
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.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
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.
Time frame: 90 days (±7 days) after treatment
Distribution of Modified Rankin Scale (mRS) Scores at 90 Days
The distribution of modified Rankin Scale (mRS) scores at 90 days after treatment.
Time frame: 90 days (±7 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.
Time frame: 90 days (±7 days)
Barthel Index Score at 90 Days
Barthel Index score assessed at 90 days after treatment.
Time frame: 90 days (±7 days)
EQ-5D-5L Score at 90 Days
Health-related quality of life assessed using the EuroQol five-dimensional five-level questionnaire (EQ-5D-5L).
Time frame: 90 days (±7 days)
Early Neurological Improvement at 24 Hours
The proportion of participants achieving early neurological improvement at 24 hours, defined as NIHSS score of 0-1 or improvement of ≥4 points from baseline.
Time frame: 24 hours (±6 hours) after treatment
Change in NIHSS Score at 24 Hours
Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours after treatment.
Time frame: 24 hours (±6 hours)
Change in NIHSS Score at 7 Days or Discharge
Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 7 days or discharge, whichever occurs first.
Time frame: 7 days (±1 day) or discharge
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