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

NCT06556446 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2800

Last updated 2024-08-16

No results posted yet for this 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.

Conditions

Interventions

DRUG

Tenecteplase and Alteplase

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

Sponsors & Collaborators

  • Swiss Stroke Trialist Association

    collaborator UNKNOWN

  • Swiss Stroke Registry

    collaborator UNKNOWN

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Thomas Meinel, MD, PhD · Insel Gruppe AG, University Hospital Bern

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-03-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Norway
  • Portugal
  • Serbia
  • Singapore
  • Slovenia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06556446 on ClinicalTrials.gov