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

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

Overview

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.

Interventions

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

Primary outcome measures

• Number of Participants with symptomatic intracerebral hemorrhage (sICH) [Time frame: Within 36 hours after IVT]
• Dichotomized good functional outcome (mRS 0-2) [Time frame: At day 90 or return to baseline (+/- 2 weeks) after admission]

Secondary outcome measures (5)

• Rate of IVT among IVT-eligible DOAC patients [Time frame: Through study completion, an average of 2 years]
• 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.]
• Categorical shift in the modified Rankin Scale (mRS) [Time frame: At Day 90 (+/-2 weeks) after admission]
• Stroke severity (NIHSS) [Time frame: At 24 hours ±8 hours]
• Ischemic stroke volume at 24 hours (mL) [Time frame: At 24 hours ±8 hours]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Switzerland · 12 centers

• Kantonsspital Aarau — Aarau
• Unispital Basel — Basel
• Inselspital Bern, University Hospital Bern — Bern
• HFR Fribourg — Fribourg
• University Hospital Geneva — Geneva
• CHUV Lausanne — Lausanne
• Kantonsspital Lucerne — Lucerne
• EOC Lugano — Lugano
• … and 4 more centers

Italy · 4 centers

• A.O.R.N. Antonio Cardarelli Hospital — Naples
• Ospedali Riuniti Hospital — Palermo
• Ospedale "Bufalini", Cesena — Perugia
• AUSL-IRCCS di Reggio Emilia — Reggio Emilia

Belgium · 2 centers

• Cliniques Universitaires Saint Luc — Brussels
• UZ Leuven — Leuven

Germany · 2 centers

• Nordwest-Krankenhaus Sanderbusch — Sanderbusch
• Universitäsklinikum Tübingen — Tübingen

Spain · 2 centers

• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Universitari de Bellvitge — Barcelona

United Kingdom · 2 centers

• Imperial College London NHS Trust — London
• King'S College Hospital Nhs Foundation Trust — London

Austria · 1 center

• Medical University of Innsbruck — Innsbruck

Canada · 1 center

• The University of British Columbia | Vancouver General Hospital — Vancouver

France · 1 center

• CHU Caen — Caen

Greece · 1 center

• Dept. of Medicine, University of Thessaly — Larissa

Norway · 1 center

• Akershus Hospital — Oslo

Portugal · 1 center

• Hospital de Egas Moniz — Lisbon

Serbia · 1 center

• Clinical Centre of Serbia, University Hospital Belgrade — Belgrade

Singapore · 1 center

• National University Hospital — Singapore

Slovenia · 1 center

• Ljubljana University Medical Centre — Ljubljana

Identifiers

NCT: NCT06556446 · 2023-01175

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗