Treatment of Acute Ischemic Stroke with Intravenous Urokinase (TASK-UK): Protocol for a Multicenter, Prospective, Real-World Study.

BACKGROUND: Intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA) and urokinase (UK) are both recommended for acute ischemic stroke (AIS) in China. Compared with rt-PA, UK is less expensive and more widely available in clinical practice. OBJECTIVE: The Treatment of Acute Ischemic Stroke with Intravenous Urokinase (TASK-UK) study aims to investigate clinical outcomes among patients with AIS who receive UK thrombolysis, and to compare efficacy and cost-effectiveness between UK and rt-PA. METHODS: TASK-UK is a multicenter, real-world observational study, with a planned sample size of 1000 patients in the UK group and 800 in the rt-PA group. This study enrolls patients with AIS who are eligible for intravenous thrombolysis from 20 participating centers and conducts follow-up until 90 days after thrombolysis. PLANNED OUTCOMES: The primary efficacy outcome is functional independence at 90 days, defined as a modified Rankin scale (mRS) score of 0-2. The primary safety outcome is symptomatic intracranial hemorrhage (sICH) occurring within 22-36 h after thrombolysis. The exploratory outcome is defined as an intergroup comparison of direct medical costs during hospitalization. DISCUSSION: The TASK-UK study will provide high-quality real-world evidence on the effectiveness and cost-effectiveness of UK thrombolysis for AIS. TRIAL REGISTRY NUMBER: NCT06194968 (ClinicalTrials.gov).