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RECRUITING
NCT06556446

Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2800

Start Date

2024-01-01

Completion Date

2026-12-31

Last Updated

2024-08-16

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tenecteplase and Alteplase

The timepoints, dose, and type of IVT will be collected as well as any complications occuring.

Locations (33)

Medical University of Innsbruck

Innsbruck, Austria

Cliniques Universitaires Saint Luc

Brussels, Belgium

UZ Leuven

Leuven, 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, 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

Lisbon, Portugal

Clinical Centre of Serbia, University Hospital Belgrade

Belgrade, Serbia

National University Hospital

Singapore, 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

Sankt 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