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Not Yet Recruiting NCT07776873

Intravenous Recombinant Human Prourokinase for Acute Medium Vessel Occlusion 4.5-24 Hours After Ischemic Stroke

Conditions: Acute Ischemic Stroke

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 616
Sponsor: The First Affiliated Hospital of Anhui Medical University

Location: The First Affiliated Hospital of Anhui Medical University Hefei Anhui

Summary

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

Inclusion Criteria: * 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. * Primary medium vessel occlusion confirmed by computed tomography angiography (CTA), involving the M2, M3, or M4 segment of the middle cerebral artery (MCA); the A1, A2, A3, or A4 segment of the anterior cerebral artery (ACA); or the P1, P2, P3, or P4 segment of the posterior cerebral artery (PCA), and identified as the responsible vessel for the signs and symptoms of acute ischemic stroke. * Perfusion mismatch on computed tomography perfusion (CTP), defined as an infarct core volume \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07776873). StuddyBuddy aggregates publicly available trial information.