Phase 2 Prourokinase Trial for Acute Ischemic Stroke
Summary
NIH has registered Phase 2 clinical trial NCT07550296 evaluating prourokinase as an additional intravenous thrombolytic infusion for acute ischemic stroke patients with confirmed medium or large vessel occlusion who show no significant clinical improvement one hour after standard IVT with alteplase. The trial will measure 24-hour recanalization rate via CTA/MRA, 90-day functional outcome via modified Rankin Scale, and safety endpoints including symptomatic intracranial hemorrhage and mortality. Patients meeting criteria (less than 2-point NIHSS reduction and persistent vessel occlusion) will receive a second prourokinase dose within 4.5 hours of symptom onset.
“Prourokinase has recently been shown to be non-inferior to alteplase with a better safety profile, and studies suggest that repeated thrombolysis may improve recanalization rates in patients without early clinical improvement after standard IVT.”
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What changed
NIH has registered a new Phase 2 clinical trial (NCT07550296) titled 'Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Prourokinase.' The trial targets acute ischemic stroke patients with confirmed medium or large vessel occlusion who demonstrate no early clinical improvement after standard intravenous thrombolysis with alteplase.
Healthcare providers and clinical investigators conducting stroke research should note that this trial evaluates a repeated thrombolysis protocol using prourokinase as an alternative agent. The study's primary endpoints include 24-hour recanalization rate, 90-day functional outcome, and safety profile. This registration represents standard clinical trial documentation activity through ClinicalTrials.gov rather than a regulatory approval or safety alert.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Prourokinase
Phase 2 NCT07550296 Kind: PHASE2 Apr 24, 2026
Abstract
Ischemic cerebrovascular disease is a common neurological disorder with high incidence, mortality, and disability. Early reperfusion to salvage the ischemic penumbra is the cornerstone of acute ischemic stroke (AIS) treatment. Current reperfusion strategies include intravenous thrombolysis (IVT) and endovascular therapy (EVT). Although alteplase is the first-line thrombolytic agent, its recanalization rate for large vessel occlusion (LVO) is only 10-20%, and for medium vessel occlusion (MeVO), approximately 50% of patients fail to achieve recanalization, leading to poor outcomes. Prourokinase has recently been shown to be non-inferior to alteplase with a better safety profile, and studies suggest that repeated thrombolysis may improve recanalization rates in patients without early clinical improvement after standard IVT. Therefore, this study aims to evaluate the efficacy and safety of an additional intravenous infusion of prourokinase in AIS patients with confirmed medium or large vessel occlusion who show no significant clinical improvement at 1 hour after standard IVT (within 4.5 hours of symptom onset). Patients without early neurological improvement (e.g., <2-point reduction in NIHSS) and persistent vessel occlusion on imaging will receive a second dose of prourokinase. The primary outcomes include 24-hour recanalization rate (by CTA/MRA), 90-day functional outcome (modified Rankin Scale), and safety endpoints (symptomatic intracranial hemorrhage, mortality). The hyp...
Conditions: Acute Ischemic Stroke
Interventions: prourokinase
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