Evaluating Safety and Effectiveness of Intravenous Thrombolysis in Adults With Ischemic Stroke Who Recently Took Direct Oral Anticoagulants

What this Trial Is About

Researchers are evaluating the safety and efficacy of intravenous thrombolysis IVT in adults who have experienced an acute ischemic stroke AIS and have taken direct oral anticoagulants DOAC within the last 48 hours. This international, multicenter, randomized trial compares IVT plus standard care to standard care alone in 906 participants to determine if IVT leads to better outcomes 90 days after treatment. Participants are randomly assigned to one of two groups one receives intravenous Tenecteplase or Alteplase along with the best medical treatment following local guidelines, while the other receives only the best medical treatment. The treatment is administered according to current recommendations from leading stroke organizations. The study aims to test whether IVT is superior in improving recovery in AIS patients with recent DOAC intake. During the study, participants are monitored and evaluated at multiple time points, including assessments of stroke severity, functional outcomes using the Modified Rankin Scale at 90 days, and quality of life questionnaires. Safety and efficacy are carefully tracked through these measures. Participants progress is followed up to about 90 days after randomization to assess the main outcomes and overall health status.

Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Direct Oral Anticoagulants Intake