Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
NCT Number: NCT06556446
Acronym: DO-IT Cohort
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Ischemic Stroke
Interventions: DRUG: Tenecteplase and Alteplase
Sponsor: Insel Gruppe AG, University Hospital Bern
Collaborators: Swiss Stroke Trialist Association|Swiss Stroke Registry
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 2800
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2026-12-31
Locations: Medical University of Innsbruck, Innsbruck, Austria|Cliniques Universitaires Saint Luc, Brussel, Belgium|UZ Leuven, Leuven, 3000, Belgium|The University of British Columbia | Vancouver General Hospital, Vancouver, Canada|CHU Caen, Caen, France|Nordwest-Krankenhaus Sanderbusch, Sanderbusch, Germany|Universitäsklinikum Tübingen, Tübingen, Germany|Dept. of Medicine, University of Thessaly, Larissa, Thessaly, 41110, Greece|A.O.R.N. Antonio Cardarelli Hospital, Naples, Italy|Ospedali Riuniti Hospital, Palermo, Italy|Ospedale "Bufalini", Cesena, Perugia, Italy|AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Italy|Akershus Hospital, Oslo, Norway|Hospital de Egas Moniz, Lisboa, Portugal|Clinical Centre of Serbia, University Hospital Belgrade, Belgrade, Serbia|National University Hospital, Singapore, 119228, Singapore|Ljubljana University Medical Centre, Ljubljana, Slovenia|Hospital de la Santa Creu i Sant Pau, Barcelona, Spain|Hospital Universitari de Bellvitge, Barcelona, Spain|Kantonsspital Aarau, Aarau, Switzerland|Unispital Basel, Basel, Switzerland|Inselspital Bern, University Hospital Bern, Bern, Switzerland|HFR Fribourg, Fribourg, Switzerland|University Hospital Geneva, Geneva, Switzerland|CHUV Lausanne, Lausanne, Switzerland|Kantonsspital Lucerne, Lucerne, Switzerland|EOC Lugano, Lugano, Switzerland|Hôpital Neuchâtelois, Neuchâtel, Switzerland|Kantonsspital St. Gallen, St. Gallen, Switzerland|Hirslanden Zurich, Zurich, Switzerland|University Hospital Zurich, Zurich, Switzerland|Imperial College London NHS Trust, London, United Kingdom|King'S College Hospital Nhs Foundation Trust, London, United Kingdom

Summary:
DO-IT is an international, prospective observational registry evaluating whether the administration of intravenous thrombolysis (IVT) is safe and improves functional outcome in ischemic stroke patients with recent direct oral anticoagulant (DOAC) intake. For this purpose, information on 2800 adult participants experiencing an acute ischemic stroke will be obtained at several high-volume international stroke centers and divided into three groups: IVT with recent DOACs intake (DOAC+IVT), and recent DOAC intake not receiving IVT (DOAC) as well as anonymized patients without DOAC receiving IVT. The patients are followed up for 90 days after the index event. treatment recommendations from the described observations. The investigators hypothesize that also more liberal decisions for IVT in patients with recent DOAC intake are not associated with an increased risk for symptomatic intracerebral hemorrhage (sICH) and result in better functional outcome at 3 month.

Primary Outcome Measures: Number of Participants with symptomatic intracerebral hemorrhage (sICH), Defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage., Within 36 hours after IVT|Dichotomized good functional outcome (mRS 0-2), Modified Rankin Scale from 0 (no disability) to 6 (death), At day 90 or return to baseline (+/- 2 weeks) after admission
Secondary Outcome Measures: Rate of IVT among IVT-eligible DOAC patients, To determine the rate of IVT in eligible patients with acute ischemic stroke and recent DOAC intake., Through study completion, an average of 2 years|All-cause mortality, major bleeding and orolingual edema, From date of randomization until the date of all-cause mortality, major bleeding or orolingual edema, whichever came first, assessed up to 7 days.|Categorical shift in the modified Rankin Scale (mRS), Modified Rankin Scale from 0 (no disability) to 6 (death), At Day 90 (+/-2 weeks) after admission|Stroke severity (NIHSS), National Institutes of Health Stroke Scale from 0 (no symptoms) to 39 (most severe symptoms), At 24 hours ±8 hours|Ischemic stroke volume at 24 hours (mL), At 24 hours ±8 hours