Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 Hours of Onset of Ischemic Stroke A Multicenter, Prospective, Observational, Real-world Study (TRANSIT)

What this Trial Is About

Stroke is a leading cause of death worldwide, with acute ischemic stroke caused by reduced blood flow to the brain often due to embolism or atherosclerosis. This study compares two thrombolytic drugs, tenecteplase and alteplase, to evaluate their safety, effectiveness, and economic benefits in real-world clinical practice. The goal is to help tailor intravenous thrombolytic treatment to different patient profiles and guide clinicians in choosing the best therapy. Participants who qualify will receive either tenecteplase at 0.25 mg/kg (up to 25 mg) or alteplase at 0.9 mg/kg (up to 90 mg), depending on their clinical condition and preferences. This real-world, multicenter, open-label study includes assessments at baseline, 24, 36, and 72 hours after treatment, with follow-up visits on day 7 or before discharge, and again at 90 days. The study aims to monitor functional outcomes, safety events like brain hemorrhage, and economic costs associated with hospitalization and recovery. During the study, participants will undergo neurological evaluations including the modified Rankin Scale at 90 days to assess recovery, and safety monitoring for symptomatic brain hemorrhage within 36 hours. Additional assessments include stroke severity scores and stroke recurrence tracking. Costs of initial hospitalization and days spent at home within 90 days will also be recorded. The total follow-up period extends to about three months after enrollment to capture both clinical and economic outcomes.

A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Stroke