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

Last updated: August 13, 2024
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Cardiac Ischemia

Treatment

Tenecteplase and Alteplase

Clinical Study ID

NCT06556446
2023-01175
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Clinical diagnosis of acute ischemic stroke with indication for IVT according toapplicable guidelines

  2. Time from symptom onset or last known well <12 hours

  3. Admission NIHSS of 2 points or more

  4. either DOAC ingestion within 48 hours prior to expected timepoint of IVT bolus, orpatient with an ongoing prescription of DOAC, but exact timepoint of last intake notverifiable in the emergency setting. (regardless of whether intravenous thrombolysiswas given) OR DOAC prescription (any intake within the last 7 days) and receivingintravenous thrombolysis

  5. Informed consent (if obtainable and in those international sites where this islegally required) for the prospective part

Exclusion

Exclusion Criteria:

  1. Patient refused the use of biological data for research purposes (Switzerland)

  2. Any acute or subacute intracranial hemorrhage (ICH) identified by admission CT orMRI on brain scan

  3. Documentation of any other absolute contraindications to IVT in the medical record

  4. Significant pre-stroke disability (mRS score of 5), including known advanceddementia

  5. Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients

  6. Pregnancy or lactating women.

Study Design

Total Participants: 2800
Treatment Group(s): 1
Primary Treatment: Tenecteplase and Alteplase
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Medical University of Innsbruck

    Innsbruck,
    Austria

    Site Not Available

  • Cliniques Universitaires Saint Luc

    Brussel,
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • The University of British Columbia | Vancouver General Hospital

    Vancouver,
    Canada

    Site Not Available

  • CHU Caen

    Caen,
    France

    Site Not Available

  • Nordwest-Krankenhaus Sanderbusch

    Sanderbusch,
    Germany

    Site Not Available

  • Universitäsklinikum Tübingen

    Tübingen,
    Germany

    Site Not Available

  • Dept. of Medicine, University of Thessaly

    Larissa, Thessaly 41110
    Greece

    Active - Recruiting

  • A.O.R.N. Antonio Cardarelli Hospital

    Naples,
    Italy

    Site Not Available

  • Ospedali Riuniti Hospital

    Palermo,
    Italy

    Site Not Available

  • Ospedale "Bufalini", Cesena

    Perugia,
    Italy

    Active - Recruiting

  • AUSL-IRCCS di Reggio Emilia

    Reggio Emilia,
    Italy

    Site Not Available

  • Akershus Hospital

    Oslo,
    Norway

    Site Not Available

  • Hospital de Egas Moniz

    Lisboa,
    Portugal

    Site Not Available

  • Clinical Centre of Serbia, University Hospital Belgrade

    Belgrade,
    Serbia

    Active - Recruiting

  • National University Hospital

    Singapore, 119228
    Singapore

    Active - Recruiting

  • Ljubljana University Medical Centre

    Ljubljana,
    Slovenia

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    Barcelona,
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Active - Recruiting

  • Kantonsspital Aarau

    Aarau,
    Switzerland

    Active - Recruiting

  • Unispital Basel

    Basel,
    Switzerland

    Active - Recruiting

  • Inselspital Bern, University Hospital Bern

    Bern,
    Switzerland

    Active - Recruiting

  • HFR Fribourg

    Fribourg,
    Switzerland

    Active - Recruiting

  • University Hospital Geneva

    Geneva,
    Switzerland

    Active - Recruiting

  • CHUV Lausanne

    Lausanne,
    Switzerland

    Active - Recruiting

  • Kantonsspital Lucerne

    Lucerne,
    Switzerland

    Active - Recruiting

  • EOC Lugano

    Lugano,
    Switzerland

    Active - Recruiting

  • Hôpital Neuchâtelois

    Neuchâtel,
    Switzerland

    Active - Recruiting

  • Kantonsspital St. Gallen

    St. Gallen,
    Switzerland

    Active - Recruiting

  • Hirslanden Zurich

    Zurich,
    Switzerland

    Active - Recruiting

  • University Hospital Zurich

    Zurich,
    Switzerland

    Active - Recruiting

  • Imperial College London NHS Trust

    London,
    United Kingdom

    Site Not Available

  • King'S College Hospital Nhs Foundation Trust

    London,
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.