Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants: the DOAC - International Thrombolysis (DO-IT) Cohort Study

Status: Recruiting
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Innsbruck
NOT_YET_RECRUITING
Innsbruck
Belgium
Cliniques Universitaires Saint Luc
NOT_YET_RECRUITING
Brussels
UZ Leuven
NOT_YET_RECRUITING
Leuven
Canada
The University of British Columbia | Vancouver General Hospital
NOT_YET_RECRUITING
Vancouver
France
CHU Caen
NOT_YET_RECRUITING
Caen
Germany
Nordwest-Krankenhaus Sanderbusch
NOT_YET_RECRUITING
Sanderbusch
Universitäsklinikum Tübingen
NOT_YET_RECRUITING
Tübingen
Greece
Dept. of Medicine, University of Thessaly
RECRUITING
Larissa
Italy
A.O.R.N. Antonio Cardarelli Hospital
NOT_YET_RECRUITING
Naples
Ospedali Riuniti Hospital
NOT_YET_RECRUITING
Palermo
Ospedale Bufalini, Cesena
RECRUITING
Perugia
AUSL-IRCCS di Reggio Emilia
NOT_YET_RECRUITING
Reggio Emilia
Norway
Akershus Hospital
NOT_YET_RECRUITING
Oslo
Portugal
Hospital de Egas Moniz
NOT_YET_RECRUITING
Lisbon
Serbia
Clinical Centre of Serbia, University Hospital Belgrade
RECRUITING
Belgrade
Singapore
National University Hospital
RECRUITING
Singapore
Slovenia
Ljubljana University Medical Centre
RECRUITING
Ljubljana
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitari de Bellvitge
NOT_YET_RECRUITING
Barcelona
Switzerland
Kantonsspital Aarau
RECRUITING
Aarau
Unispital Basel
RECRUITING
Basel
Inselspital Bern, University Hospital Bern
RECRUITING
Bern
HFR Fribourg
RECRUITING
Fribourg
University Hospital Geneva
RECRUITING
Geneva
CHUV Lausanne
RECRUITING
Lausanne
Kantonsspital Lucerne
RECRUITING
Lucerne
EOC Lugano
RECRUITING
Lugano
Hôpital Neuchâtelois
RECRUITING
Neuchâtel
Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Hirslanden Zurich
RECRUITING
Zurich
University Hospital Zurich
RECRUITING
Zurich
United Kingdom
Imperial College London NHS Trust
NOT_YET_RECRUITING
London
King'S College Hospital Nhs Foundation Trust
NOT_YET_RECRUITING
London
Contact Information
Primary
Thomas Meinel, MD, PhD
thomas.meinel@insel.ch
+41 31 66 4 25 67
Backup
Freschta Zipser-Mohammadzada, PhD
nctu@insel.ch
+41 31 63 2 60 83
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2800
Treatments
DOAC+IVT
Acute ischemic Stroke patients with recent DOACs intake receive IVT.
DOAC
Acute ischemic Stroke patients with recent DOAC intake do not receive IVT.
IVT Controls
Acute ischemic Stroke patients without recent DOAC intake receive IVT.
Related Therapeutic Areas
Sponsors
Collaborators: Swiss Stroke Registry, Swiss Stroke Trialist Association
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov