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NCT Number: NCT06556446

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

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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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Innsbruck, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Tenecteplase and Alteplase

Drug

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

Primary outcomes

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

    Time frame: 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.

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

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

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

Secondary outcomes

  1. Rate of IVT among IVT-eligible DOAC patients

    Time frame: Through study completion, an average of 2 years

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

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

    Time frame: 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)

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

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

  4. Stroke severity (NIHSS)

    Time frame: At 24 hours ±8 hours

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

  5. Ischemic stroke volume at 24 hours (mL)

    Time frame: At 24 hours ±8 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Freschta Zipser-Mohammadzada, PhD

CONTACT

[email protected]

+41 31 63 2 60 83

Thomas Meinel, MD, PhD

CONTACT

[email protected]

+41 31 66 4 25 67

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Swiss Stroke Registry
  • Swiss Stroke Trialist Association

Registry information

Official study 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

Acronym: DO-IT Cohort

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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