ABSTRACT NUMBER: ESOC2026OT8 SAFETY AND EFFICACY OF INTRAVENOUS THROMBOLYSIS IN PATIENTS WITH ISCHEMIC STROKE ON TREATMENT WITH DIRECT ORAL ANTICOAGULANTS: DO-IT – THE DOAC INTRAVENOUS THROMBOLYSIS TRIAL (DO-IT)

Abstract Background and aims Intravenous thrombolysis (IVT) effectively reduces disability in acute ischemic stroke (AIS), with a number needed to treat of 10 when given early. Yet, recent direct oral anticoagulant (DOAC) use—affecting ~20% of eligible patients—is the most common reason IVT is withheld. Methods Guidelines currently advise against IVT after recent DOAC use, despite limited evidence supporting this caution. Preclinical and observational data have not shown increased intracranial bleeding with off-label IVT, and no randomized trial has assessed its safety or efficacy in this setting. This trial aims to evaluate the safety and effectiveness of IVT in patients with AIS who have taken a DOAC within the past 48 hours. Results DO-IT is an international, multicenter trial randomizing 906 patients (1:1) to IVT or best medical therapy. Main inclusion criteria are DOAC use (≤ 48 h or unknown) and disabling AIS within the thrombolysis window (randomization ≤4 h 15 min; treatment ≤ 4 h 30 min). Exclusions include standard IVT contraindications and prior DOAC reversal. Conclusions The primary efficacy outcome is 90-days (±2 weeks) functional status on the modified Rankin Scale using a shift analysis. The primary safety outcome is symptomatic intracranial hemorrhage (ECASS-2 definition). Conflict of interest