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Ischemic StrokeDO-IT CohortNCT06556446

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

An observational study of Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 33 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Tenecteplase and Alteplase
How many people
2,800 participants
Where
33 sitesin 15 countries
Study dates
1 Jan 2024to 31 Dec 2026
How long will I take part?
90 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The in- and exclusion criteria emulate a target trial, thus the investigators want to study a population that is - except from recent DOAC ingestion - eligible for IVT as per standard of care.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

33 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Thomas Meinel, MD, PhD contact

+41 31 66 4 25 67

thomas.meinel@insel.ch

Freschta Zipser-Mohammadzada, PhD contact

+41 31 63 2 60 83

nctu@insel.ch

33 sites in 15 countries

Switzerland12 sites, 12 recruiting

  • Kantonsspital Aarau

    Aarau

    Timo Kahles

    Recruiting

  • Unispital Basel

    Basel

    Gerrit Grosse

    Recruiting

  • Inselspital Bern, University Hospital Bern

    Bern

    Freschta Zipser-Mohammadzada

    Recruiting

  • HFR Fribourg

    Fribourg

    Friedrich Medlin

    Recruiting

  • University Hospital Geneva

    Geneva

    Emmanuel Carrera

    Recruiting

  • CHUV Lausanne

    Lausanne

    Patrik Michel

    Recruiting

  • Kantonsspital Lucerne

    Lucerne

    Manuel Bolognese

    Recruiting

  • EOC Lugano

    Lugano

    Carlo Cereda

    Recruiting

  • Hôpital Neuchâtelois

    Neuchâtel

    Susanne Renaud

    Recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen

    Gian Marco De Marchis

    Recruiting

  • Hirslanden Zurich

    Zurich

    Nils Peters

    Recruiting

  • University Hospital Zurich

    Zurich

    Laura Westphal

    Recruiting

Other trials in Switzerland

Italy4 sites, 4 recruiting

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

    Naples

    Paolo Candelaresi, MD

    Paolo Candelaresi, MD

    Not yet recruiting

  • Ospedali Riuniti Hospital

    Palermo

    Marina Mannino, MD

    Marina Mannino, MD

    Not yet recruiting

  • Ospedale "Bufalini", Cesena

    Perugia

    Michele Romoli, MD, PhD, michele.romoli@auslromagna.it

    Michele Romoli, MD

    Recruiting

  • AUSL-IRCCS di Reggio Emilia

    Reggio Emilia

    Marialuisa Zedde, MD

    Marialuisa Zedde

    Not yet recruiting

Other trials in Italy

Belgium2 sites, 2 recruiting

  • Cliniques Universitaires Saint Luc

    Brussels

    Pasquale Scoppettuolo, MD

    Pasquale Scoppettuolo, MD

    Not yet recruiting

  • UZ Leuven

    Leuven, 3000

    Robin Lemmens, Prof

    Not yet recruiting

Other trials in Belgium

Germany2 sites, 2 recruiting

  • Nordwest-Krankenhaus Sanderbusch

    Sanderbusch

    Pawel Kermer

    Pawel Kermer, MD

    Not yet recruiting

  • Universitäsklinikum Tübingen

    Tübingen

    Julia Zeller

    Sven Poli, MD

    Not yet recruiting

Other trials in Germany

Spain2 sites, 2 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

    Marina Guasch-Jiménez, MD

    Marina Guasch-Jiménez, MD

    Recruiting

  • Hospital Universitari de Bellvitge

    Barcelona

    Pere Cardona, MD

    Pere Cardona, MD

    Not yet recruiting

Other trials in Spain

United Kingdom2 sites, 2 recruiting

  • Imperial College London NHS Trust

    London

    Lucio D'Anna, MD

    Lucio D'Anna, MD

    Not yet recruiting

  • King'S College Hospital Nhs Foundation Trust

    London

    Con Tibajia

    Not yet recruiting

Other trials in United Kingdom

Austria1 site, 1 recruiting

  • Medical University of Innsbruck

    Innsbruck

    Christian Böhme, MD, PhD

    Not yet recruiting

Other trials in Austria

Canada1 site, 1 recruiting

  • The University of British Columbia | Vancouver General Hospital

    Vancouver

    Thalia Field

    Not yet recruiting

Other trials in Canada

France1 site, 1 recruiting

  • CHU Caen

    Caen

    Marion Boulanger, MD

    Not yet recruiting

Other trials in France

Greece1 site, 1 recruiting

  • Dept. of Medicine, University of Thessaly

    Larissa, Thessaly, 41110

    George Ntaios, MD, PhD

    Dimitra Papadimitriou, MD

    Recruiting

Other trials in Greece

Norway1 site, 1 recruiting

  • Akershus Hospital

    Oslo

    Espen Kristoffersen, MD

    Not yet recruiting

Other trials in Norway

Portugal1 site, 1 recruiting

  • Hospital de Egas Moniz

    Lisbon

    Mafalda Oliveira, mafoliveira@chlo.min-saude.pt

    Joao Pedro Marto, MD

    Not yet recruiting

Other trials in Portugal

Serbia1 site, 1 recruiting

  • Clinical Centre of Serbia, University Hospital Belgrade

    Belgrade

    Visnja Padjen, MD

    Visnja Padjen, MD

    Recruiting

Other trials in Serbia

Singapore1 site, 1 recruiting

  • National University Hospital

    Singapore, 119228

    Benjamin Tan, MD

    Mayank Dalakoti, MD

    Recruiting

Other trials in Singapore

Slovenia1 site, 1 recruiting

  • Ljubljana University Medical Centre

    Ljubljana

    Senta Frol, MD, sentafrol@gmail.com

    Senta Frol, MD

    Recruiting

Other trials in Slovenia

About this study

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

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.

Conditions
Ischemic Stroke
Being tested
Tenecteplase and Alteplase
Keywords
DOAC (Direct Oral AntiCoagulants), NOAC (Novel Oral AntiCoagulants), Anticoagulation, r-tPA (tissue-type plasminogen activator), Alteplase, Tenecteplase, Rivaroxaban, Apixaban, Dabigatran, Edoxaban
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tenecteplase and AlteplaseDrug

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

Study groups in NCT06556446
Study groupRoleWhat they receive
DOAC+IVTAcute ischemic Stroke patients with recent DOACs intake receive IVT.
Receives: Drug: Tenecteplase and Alteplase
DOACAcute ischemic Stroke patients with recent DOAC intake do not receive IVT.
IVT ControlsAcute ischemic Stroke patients without recent DOAC intake receive IVT.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with symptomatic intracerebral hemorrhage (sICH)

    Defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage.

    Measured: Within 36 hours after IVT

  2. Dichotomized good functional outcome (mRS 0-2)

    Modified Rankin Scale from 0 (no disability) to 6 (death)

    Measured: At day 90 or return to baseline (+/- 2 weeks) after admission

Secondary outcomes (5)

  1. Rate of IVT among IVT-eligible DOAC patients

    To determine the rate of IVT in eligible patients with acute ischemic stroke and recent DOAC intake.

    Measured: Through study completion, an average of 2 years

  2. All-cause mortality, major bleeding and orolingual edema

    Measured: From date of randomization until the date of all-cause mortality, major bleeding or orolingual edema, whichever came first, assessed up to 7 days.

  3. Categorical shift in the modified Rankin Scale (mRS)

    Modified Rankin Scale from 0 (no disability) to 6 (death)

    Measured: At Day 90 (+/-2 weeks) after admission

  4. Stroke severity (NIHSS)

    National Institutes of Health Stroke Scale from 0 (no symptoms) to 39 (most severe symptoms)

    Measured: At 24 hours ±8 hours

  5. Ischemic stroke volume at 24 hours (mL)

    Measured: At 24 hours ±8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2024
  2. Study start1 Jan 2024
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,800 participants (estimated)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06556446
Sponsor's protocol ID
2023-01175
Other IDs
2023
Acronym
DO-IT Cohort
Status last verified
Aug 2024
First submitted
24 Jun 2024
Last updated
16 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPDMA of similar observational cohort studies is planned.

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Insel Gruppe AG, University Hospital Bern at 33 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Switzerland, Italy, Belgium, Germany, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Thomas Meinel, MD, PhD (+41 31 66 4 25 67, thomas.meinel@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with symptomatic intracerebral hemorrhage (sICH) (time frame: Within 36 hours after IVT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06556446.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.

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