Safety and Efficacy of Intravenous Thrombolysis in Patients with Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants:
DO-IT – The DOAC Intravenous Thrombolysis trial
DO-IT Consent Video: Patient information on the DO-IT trial
Short description
DO-IT is a multicenter, prospective, randomized, open label, blinded endpoint (PROBE) trial , evaluating the safety and efficacy of intravenous thrombolysis (IVT) in patients with an acute ischemic stroke (AIS) and recent intake of direct oral anticoagulants (DOACs). 906 patients will be randomly assigned to either the standard or the experimental arm with a ratio of 1:1 (453 patients per group). In the the experimental arm, patients will receive IVT with alteplase or tenecteplase plus best medical treatment (BMT). In the standard arm, patients will receive BMT.
Objective
The primary objective is to evaluate whether IVT with either alteplase or tenecteplase is superior to best medical treatment for achieving better outcome (functional outcome quantified by a shift on the modified Rankin Scale, mRS) at 90 days in AIS patients with recent DOAC intake who are otherwise eligible for IVT according to local standards of care.
Secondary objectives include to determine the efficacy of IVT regarding stroke severity at 24 hours and economic analysis on the cost-effectiveness of IVT.
Principle investigators
PD Dr.med. Thomas Meinel
Department of Neurology
University Hospital Bern Inselspital
Bern, Switzerland
Prof. Dr. med. Luciana Catanese
Department of Neurology
Hamilton Health Sciences
Hamilton, Canada