Testing Safety and Effectiveness of Clot-Busting Drugs for Stroke Patients Taking Factor Xa Inhibitors A Phase 3 Study Comparing Intravenous Thrombolysis to Standard Care

What this Trial Is About

Researchers are evaluating whether stroke patients who have recently taken Factor Xa FXa inhibitors, a type of blood thinner, can safely receive intravenous thrombolysis IVT, a clot-busting emergency treatment. Current guidelines advise against IVT within 48 hours of FXa inhibitor use due to bleeding risks, but new studies suggest IVT might be safe for these patients. This phase III multicenter trial aims to provide solid evidence on the safety and effectiveness of IVT in this group, potentially changing stroke treatment guidelines to help more patients. Participants are randomly assigned to one of two groups one receiving IVT with either alteplase or tenecteplase according to hospital procedures, and the other receiving standard care with aspirin but no IVT. The IVT group gets specific doses of the drugs either as an infusion or a single bolus. The study compares early neurological improvement and safety outcomes between these groups. The trial runs from 2025 to 2029, with patient follow-up lasting 90 days. During the study, researchers monitor neurological function using standardized scales such as the NIH Stroke Scale and brain imaging to measure infarct size and bleeding events. They also assess functional outcomes and mortality up to 90 days after treatment. Safety monitoring includes checking for symptomatic brain bleeding within 36 hours. The trial uses a randomized, open-label design with blinded outcome assessment, aiming to enroll 300 patients across multiple centers.

Thrombolysis in Factor Xa-inhibitors Trial