DO-IT
Research type
Research Study
Full title
Safety and Efficacy of Intravenous Thrombolysis in Patients with Ischemic Stroke on Treatment with Direct Oral Anticoagulants: DO-IT – The DOAC Intravenous Thrombolysis trial
IRAS ID
1012903
Contact name
Thomas Meinel
Contact email
Sponsor organisation
Insel Gruppe AG, Inselspital (University Hospital) Bern
Eudract number
2024-515561-34
Clinicaltrials.gov Identifier
Research summary
The DO-IT (Direct Oral Anticoagulants in Thrombolysis) trial is an international clinical study investigating whether stroke patients who are taking direct oral anticoagulants (DOACs) can safely benefit from thrombolysis—a clot-busting treatment given in the early stages of acute ischemic stroke. Currently, patients on DOACs are often excluded from thrombolysis due to concerns about bleeding. However, this cautious approach may deny them access to a potentially life-saving therapy, since no evidence of harm associated with thrombolysis in acute ischemic stroke patients with recent DOAC intake was found. DO-IT aims to answer a crucial question: Is it safe and effective to give thrombolysis to patients on DOACs? If so, this could lead to major improvements in stroke care for thousands of patients each year.
The study compares two groups of patients:
Those receiving best medical treatment plus intravenous thrombolysis (Tenecteplase or Alteplase) and those receiving best medical treatment only. Patients are randomly assigned to one of the two groups. A total of 906 patients will be enrolled across multiple hospitals in Europe, the UK, Canada, and Australia. Participating sites include academic and non-academic stroke centers, all with 24/7 access to emergency stroke care.
Eligible participants are adults with acute ischemic stroke who have taken a DOAC in the previous 48 hours and meet standard eligibility criteria for thrombolysis, except for DOAC use. Participants will be followed for 90 days to assess their recovery, focusing on functional independence using the modified Rankin Scale. Safety outcomes, such as the risk of bleeding in the brain, will also be evaluated.
The DO-IT trial is expected to deliver critical evidence to help stroke physicians make informed treatment decisions and to update clinical guidelines. It is designed with patient representatives and supported by national research networks.REC name
Wales REC 5
REC reference
26/WA/0147
Date of REC Opinion
23 Jun 2026
REC opinion
Further Information Favourable Opinion