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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Primary outcome measure(s)

• Number of Participants with symptomatic intracerebral hemorrhage (sICH) — Within 36 hours after IVT
  Defined as worsening of at least 4 points on the National Institutes of Health Stroke Scale and attributed to radiologically evident intracranial hemorrhage.
• Dichotomized good functional outcome (mRS 0-2) — At day 90 or return to baseline (+/- 2 weeks) after admission
  Modified Rankin Scale from 0 (no disability) to 6 (death)

Trial sites (33)

More Insel Gruppe AG, University Hospital Bern trials in Canada

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