POST‐UK (Adjunctive Intra‐Arterial Urokinase After Successful Endovascular Thrombectomy in Patients With Large‐Vessel Occlusion Stroke): Study Protocol of a Multicenter, Prospective, Randomized, Open‐Label, Blinded‐End Point Trial

Abstract

BACKGROUND Intra‐arterial infusion of an adjunctive thrombolytic agent after macrovascular recanalization by endovascular thrombectomy was regarded as a promising strategy to promote outcomes of patients with stroke. Given the characteristics of urokinase as an affordable, available, and widely applied medication, especially in Eastern countries, this trial aims to assess the safety and efficacy of intra‐arterial urokinase as adjunct to endovascular thrombectomy in improving outcomes among patients with anterior large‐vessel occlusion stroke after excellent to complete reperfusion. METHODS The POST‐UK (Adjunctive Intra‐Arterial Urokinase After Successful Endovascular Thrombectomy in Patients With Large Vessel Occlusion Stroke) trial is a multicenter, prospective, randomized, open‐label, blinded‐end point trial conducted in China. The planned sample size is 498. Those eligible patients with anterior circulation large‐vessel occlusion stroke and achieving excellent to complete reperfusion by endovascular thrombectomy are planned to be consecutively randomized in a 1:1 ratio to the experimental group (a single dose of intra‐arterial urokinase) or to standard of care. RESULTS The primary outcome is a freedom from disability (modified Rankin Scale score of 0–1) at 90±7 days. The safety outcomes are mortality within 90±7 days and symptomatic intracranial hemorrhage within 48 hours. CONCLUSION The POST‐UK trial will provide valuable insight of efficacy and safety of intra‐arterial urokinase in patients with large‐vessel occlusion stroke after achieving excellent to complete reperfusion by endovascular thrombectomy.