The DO-IT trial is an ongoing international, multicenter RCT randomizing 906 patients with acute ischemic stroke and recent DOAC use to intravenous thrombolysis or best medical therapy.
RCT (n=906)
1:1
Sí
Does intravenous thrombolysis improve functional status and maintain safety in patients with acute ischemic stroke on recent DOAC treatment?
The DO-IT trial will provide randomized evidence on the safety and efficacy of intravenous thrombolysis for acute ischemic stroke in patients with recent DOAC use, a practice currently advised against by guidelines.
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
Nerea Fernandez Trigo on Behalf of the Do-It Study Group (Fri,) conducted a rct in acute ischemic stroke (AIS) (n=906). Intravenous thrombolysis (IVT) vs. best medical therapy was evaluated on 90-days (±2 weeks) functional status on the modified Rankin Scale using a shift analysis. The DO-IT trial is an ongoing international, multicenter RCT randomizing 906 patients with acute ischemic stroke and recent DOAC use to intravenous thrombolysis or best medical therapy.