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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (5)

• Rate of IVT among IVT-eligible DOAC patients [Срок оценки: Through study completion, an average of 2 years]
• All-cause mortality, major bleeding and orolingual edema [Срок оценки: 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) [Срок оценки: At Day 90 (+/-2 weeks) after admission]
• Stroke severity (NIHSS) [Срок оценки: At 24 hours ±8 hours]
• Ischemic stroke volume at 24 hours (mL) [Срок оценки: At 24 hours ±8 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 12 центров

• 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
• … и ещё 4 центра

Италия · 4 центра

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

Бельгия · 2 центра

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

Германия · 2 центра

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

Испания · 2 центра

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

Великобритания · 2 центра

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

Австрия · 1 центр

• Medical University of Innsbruck — Innsbruck

Канада · 1 центр

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

Франция · 1 центр

• CHU Caen — Caen

Греция · 1 центр

• Dept. of Medicine, University of Thessaly — Larissa

Норвегия · 1 центр

• Akershus Hospital — Oslo

Португалия · 1 центр

• Hospital de Egas Moniz — Lisbon

Сербия · 1 центр

• Clinical Centre of Serbia, University Hospital Belgrade — Belgrade

Сингапур · 1 центр

• National University Hospital — Singapore

Словения · 1 центр

• Ljubljana University Medical Centre — Ljubljana

Идентификаторы

NCT: NCT06556446 · 2023-01175

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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