About this trial
The HOPE-MeVO study aims to evaluate the efficacy and safety of intravenous recombinant human prourokinase (rhPro-UK) in patients with acute ischemic stroke due to medium vessel occlusion presenting 4.5 to 24 hours after stroke onset or last known well. Eligible patients will be selected based on CT perfusion imaging and randomly assigned to receive rhPro-UK plus standard medical treatment or standard medical treatment alone. The primary objective is to determine whether rhPro-UK improves functional outcome at 90 days.
Eligibility criteria
Qualifiers
Age ≥18 years.
Pre-stroke modified Rankin Scale (mRS) score of 0-1.
Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6, or an NIHSS score of 4-5 with a disabling neurological deficit, including but not limited to hemianopia, aphasia, or impaired hand motor function.
Time from last known well of 4.5 to 24 hours, including wake-up stroke or unwitnessed stroke. Symptom onset is defined as the last time the participant was known to be well.
Disqualifiers
Planned direct endovascular treatment (EVT).
Known history of severe hypersensitivity to recombinant human prourokinase, human albumin, mannitol, iodinated contrast media, or medications used for study-related examinations or treatment.
Rapidly improving clinical symptoms such that, in the investigator's judgment, the participant is not suitable for the study intervention.
Seizure at stroke onset when, in the investigator's judgment, the neurological deficit may be attributable to postictal Todd paralysis or another non-ischemic cause.
Trial design
Treatments tested in this trial
- Recombinant Human Prourokinase for Injection (rhPro-UK)
- Standard medical treatment (SMT)