Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
- Registration Number
- NCT06556446
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2800
- Clinical diagnosis of acute ischemic stroke with indication for IVT according to applicable guidelines
- Time from symptom onset or last known well <12 hours
- Admission NIHSS of 2 points or more
- either DOAC ingestion within 48 hours prior to expected timepoint of IVT bolus, or patient with an ongoing prescription of DOAC, but exact timepoint of last intake not verifiable in the emergency setting. (regardless of whether intravenous thrombolysis was given) OR DOAC prescription (any intake within the last 7 days) and receiving intravenous thrombolysis
- Informed consent (if obtainable and in those international sites where this is legally required) for the prospective part
- Patient refused the use of biological data for research purposes (Switzerland)
- Any acute or subacute intracranial hemorrhage (ICH) identified by admission CT or MRI on brain scan
- Documentation of any other absolute contraindications to IVT in the medical record
- Significant pre-stroke disability (mRS score of 5), including known advanced dementia
- Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients
- Pregnancy or lactating women.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description DOAC+IVT Tenecteplase and Alteplase Acute ischemic Stroke patients with recent DOACs intake receive IVT.
- Primary Outcome Measures
Name Time Method Dichotomized good functional outcome (mRS 0-2) At day 90 or return to baseline (+/- 2 weeks) after admission Modified Rankin Scale from 0 (no disability) to 6 (death)
Number of Participants with symptomatic intracerebral hemorrhage (sICH) Within 36 hours after IVT Defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage.
- Secondary Outcome Measures
Name Time Method Rate of IVT among IVT-eligible DOAC patients Through study completion, an average of 2 years To determine the rate of IVT in eligible patients with acute ischemic stroke and recent DOAC intake.
Categorical shift in the modified Rankin Scale (mRS) At Day 90 (+/-2 weeks) after admission Modified Rankin Scale from 0 (no disability) to 6 (death)
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. Stroke severity (NIHSS) At 24 hours ±8 hours National Institutes of Health Stroke Scale from 0 (no symptoms) to 39 (most severe symptoms)
Ischemic stroke volume at 24 hours (mL) At 24 hours ±8 hours
Trial Locations
- Locations (33)
King'S College Hospital Nhs Foundation Trust
🇬🇧London, United Kingdom
Medical University of Innsbruck
🇦🇹Innsbruck, Austria
The University of British Columbia | Vancouver General Hospital
🇨🇦Vancouver, Canada
CHU Caen
🇫🇷Caen, France
Nordwest-Krankenhaus Sanderbusch
🇩🇪Sanderbusch, Germany
Universitäsklinikum Tübingen
🇩🇪Tübingen, Germany
A.O.R.N. Antonio Cardarelli Hospital
🇮🇹Naples, Italy
Ospedale "Bufalini", Cesena
🇮🇹Perugia, Italy
AUSL-IRCCS di Reggio Emilia
🇮🇹Reggio Emilia, Italy
Ospedali Riuniti Hospital
🇮🇹Palermo, Italy
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
University Hospital Geneva
🇨🇭Geneva, Switzerland
CHUV Lausanne
🇨🇭Lausanne, Switzerland
EOC Lugano
🇨🇭Lugano, Switzerland
Hôpital Neuchâtelois
🇨🇭Neuchâtel, Switzerland
Hirslanden Zurich
🇨🇭Zurich, Switzerland
University Hospital Zurich
🇨🇭Zurich, Switzerland
Imperial College London NHS Trust
🇬🇧London, United Kingdom
Clinical Centre of Serbia, University Hospital Belgrade
🇷🇸Belgrade, Serbia
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Kantonsspital Lucerne
🇨🇭Lucerne, Switzerland
Dept. of Medicine, University of Thessaly
🇬🇷Larissa, Thessaly, Greece
National University Hospital
🇸🇬Singapore, Singapore
Unispital Basel
🇨🇭Basel, Switzerland
Kantonsspital St. Gallen
🇨🇭St. Gallen, Switzerland
UZ Leuven
🇧🇪Leuven, Belgium
Hospital de Egas Moniz
🇵🇹Lisboa, Portugal
Cliniques Universitaires Saint Luc
🇧🇪Brussel, Belgium
Akershus Hospital
🇳🇴Oslo, Norway
Ljubljana University Medical Centre
🇸🇮Ljubljana, Slovenia
Inselspital Bern, University Hospital Bern
🇨🇭Bern, Switzerland
HFR Fribourg
🇨🇭Fribourg, Switzerland