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NCT06556446Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 16 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2800 (estimated)
First submitted
24 Jun 2024
Start date
1 Jan 2024
Primary completion date
31 Mar 2026
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Diseases
Stroke
NCT number
NCT06556446

What you commit to

  • Study type: Observational
  • Planned participants: 2800
  • From 1 Jan 2024 to the primary completion date, 31 Mar 2026
  • 33 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any acute or subacute intracranial hemorrhage (ICH) identified by admission CT or MRI on brain scan
  • Significant pre-stroke disability (mRS score of 5), including known advanced dementia

Other

  • Patient refused the use of biological data for research purposes (Switzerland)
  • Documentation of any other absolute contraindications to IVT in the medical record
  • Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients
  • Pregnancy or lactating women.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medical University of Innsbruck
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InnsbruckAustriaNot yet recruiting
Cliniques universitaires Saint-Luc
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BrusselsBelgiumNot yet recruiting
UZ Leuven
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LeuvenBelgiumNot yet recruiting
The University of British Columbia | Vancouver General Hospital
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VancouverCanadaNot yet recruiting
Kantonsspital Aarau
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AarauSwitzerlandRecruiting
Unispital Basel
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BaselSwitzerlandRecruiting
Inselspital Bern University Hospital Bern
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BernSwitzerlandRecruiting
HFR Fribourg
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FribourgSwitzerlandRecruiting
University Hospital Geneva
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GenevaSwitzerlandRecruiting
CHUV Lausanne
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LausanneSwitzerlandRecruiting
Kantonsspital Lucerne
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LucerneSwitzerlandRecruiting
EOC Lugano
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LuganoSwitzerlandRecruiting
Hôpital Neuchâtelois
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NeuchâtelSwitzerlandRecruiting
Kantonsspital St. Gallen
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Sankt GallenSwitzerlandRecruiting
Hirslanden Zurich
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ZurichSwitzerlandRecruiting
University Hospital Zurich
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ZurichSwitzerlandRecruiting
Nordwest-Krankenhaus Sanderbusch
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SanderbuschGermanyNot yet recruiting
Universitäsklinikum Tübingen
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TübingenGermanyNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitari de Bellvitge
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BarcelonaSpainNot yet recruiting
CHU Caen
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CaenFranceNot yet recruiting
Imperial College London NHS Trust
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LondonUnited KingdomNot yet recruiting
King's College Hospital NHS Foundation Trust
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LondonUnited KingdomNot yet recruiting
Dept. of Medicine, University of Thessaly
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LarissaGreeceRecruiting
A.O.R.N. Antonio Cardarelli Hospital
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NaplesItalyNot yet recruiting
Ospedali Riuniti Hospital
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PalermoItalyNot yet recruiting
Ospedale "Bufalini", Cesena
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PerugiaItalyRecruiting
AUSL IRCCS di Reggio Emilia
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Reggio EmiliaItalyNot yet recruiting
Akershus Hospital:
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OsloNorwayNot yet recruiting
Hospital de Egas Moniz
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LisbonPortugalNot yet recruiting
Clinical Centre of Serbia, University Hospital Belgrade
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BelgradeSerbiaRecruiting
National University Hospital
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SingaporeSingaporeRecruiting
Ljubljana University Medical Centre
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LjubljanaSloveniaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.