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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DOAC+IVT

Acute ischemic Stroke patients with recent DOACs intake receive IVT.

Tenecteplase and Alteplase

Intervention Type DRUG

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

DOAC

Acute ischemic Stroke patients with recent DOAC intake do not receive IVT.

No interventions assigned to this group

IVT Controls

Acute ischemic Stroke patients without recent DOAC intake receive IVT.

No interventions assigned to this group

Interventions

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Tenecteplase and Alteplase

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Clinical diagnosis of acute ischemic stroke with indication for IVT according to applicable 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, 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
5. Informed consent (if obtainable and in those international sites where this is legally required) for the prospective part

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 or MRI 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 advanced dementia
5. Known (serious) sensitivity to Alteplase/Tenecteplase or any of the excipients
6. Pregnancy or lactating women.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Meinel, MD, PhD

Role: STUDY_DIRECTOR

Insel Gruppe AG, University Hospital Bern

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Marialuisa Zedde, MD

Role: primary

Espen Kristoffersen, MD

Role: primary

Mafalda Oliveira

Role: primary

[email protected]

Visnja Padjen, MD

Role: primary

Benjamin Tan, MD

Role: primary

Senta Frol, MD

Role: primary

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Related Clinical Trials

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Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on DOAC

Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke

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Detailed Description

Conditions

Study Design

Study Groups

DOAC+IVT

Tenecteplase and Alteplase

DOAC

IVT Controls

Interventions

Tenecteplase and Alteplase

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Swiss Stroke Trialist Association

Swiss Stroke Registry

Insel Gruppe AG, University Hospital Bern

Responsible Party

Principal Investigators

Thomas Meinel, MD, PhD

Locations

Medical University of Innsbruck

Cliniques Universitaires Saint Luc

UZ Leuven

The University of British Columbia | Vancouver General Hospital

CHU Caen

Nordwest-Krankenhaus Sanderbusch

Universitäsklinikum Tübingen

Dept. of Medicine, University of Thessaly

A.O.R.N. Antonio Cardarelli Hospital

Ospedali Riuniti Hospital

Ospedale "Bufalini", Cesena

AUSL-IRCCS di Reggio Emilia

Akershus Hospital

Hospital de Egas Moniz

Clinical Centre of Serbia, University Hospital Belgrade

National University Hospital

Ljubljana University Medical Centre

Hospital de la Santa Creu i Sant Pau

Hospital Universitari de Bellvitge

Kantonsspital Aarau

Unispital Basel

Inselspital Bern, University Hospital Bern

HFR Fribourg

University Hospital Geneva

CHUV Lausanne

Kantonsspital Lucerne

EOC Lugano

Hôpital Neuchâtelois

Kantonsspital St. Gallen

Hirslanden Zurich

University Hospital Zurich

Imperial College London NHS Trust

King'S College Hospital Nhs Foundation Trust

Countries

Central Contacts

Thomas Meinel, MD, PhD

Freschta Zipser-Mohammadzada, PhD

Facility Contacts

Pasquale Scoppettuolo, MD

Thalia Field

Pawel Kermer

Julia Zeller

Paolo Candelaresi, MD

Marina Mannino, MD

Michele Romoli, MD, PhD

Marialuisa Zedde, MD

Espen Kristoffersen, MD

Mafalda Oliveira

Visnja Padjen, MD