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ESOC 2026 | The ongoing DO-IT trial: intravenous thrombolysis in patients with ischemic stroke on DOACs

Thomas Meinel, MD, PhD, Bern University Hospital, and University of Bern, Bern, Switzerland, discusses the DO-IT trial (NCT06556446), which is exploring the safety and efficacy of intravenous thrombolysis in patients with ischemic stroke and recent ingestion of direct oral anticoagulants (DOACs). Dr Meinel highlights that the trial aims to include 906 patients and is expected to be completed in 2028. This interview took place at the 12th European Stroke Organisation Conference (ESOC) in Maastricht, The Netherlands.

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Transcript

So the DO-IT trial is an international multicenter randomized trial. It runs in over 10 countries and over 100 sites globally. And the aim of the trial is to test whether intravenous thrombolysis, which is a standard treatment for ischemic stroke, is also possible in patients that take a certain type of blood-thinning medications, so DOAC, and currently these patients are excluded from intravenous thrombolysis, and it’s every fifth patient that we would otherwise thrombolyze who is on this medication...

So the DO-IT trial is an international multicenter randomized trial. It runs in over 10 countries and over 100 sites globally. And the aim of the trial is to test whether intravenous thrombolysis, which is a standard treatment for ischemic stroke, is also possible in patients that take a certain type of blood-thinning medications, so DOAC, and currently these patients are excluded from intravenous thrombolysis, and it’s every fifth patient that we would otherwise thrombolyze who is on this medication. So it’s a significant amount of patients, and they are increasing every year due to the aging population and the increasing prevalence of atrial fibrillation. Previously, we have observational data that is quite reassuring, and we also have indirect randomized data from humans that thrombolysis in this scenario is not harmful. So we are testing this. We are currently over 200 patients, and we aim for including 906 patients, and the trial is expected to be finished in 2028. So the efficacy, we don’t have data. For the safety, we have the interim analysis of the first 10% of the population, and there we are waiting for the DSMB recommendation. But I would be surprised if there was any safety signal.

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Disclosures

Speaker fees: Boehringer Ingelheim; Consulting fees: Medtronic, Perospheretech; Research contracts: Boehringer Ingelheim (provision of study drug / compensation of study drug for the DO-IT trial), Swiss National Science Foundation, Swiss Heart Foundation, Horten Health Foundation, Bangerter Rhyner Foundation, Baasch Medicus Foundation, DFG, CIHR, PHRC, British & Dutch Heart Foundations; Clinical trial steering committee: ELAPSE, DO-IT, PASSION; Other: Industry sponsorships for the ESO Stroke Master programme and ESO Stroke Winter School.