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Direct oral anticoagulants for the treatment of cerebral venous thrombosis – a protocol of an international phase IV study

Authors :
Anita van de Munckhof
Mayte Sánchez van Kammen
Katarzyna Krzywicka
Sanjith Aaron
Diana Aguiar de Sousa
Florina Antochi
Antonio Arauz
Miguel A. Barboza
Adriana B. Conforto
Francesco Dentali
Daniel Galdames Contreras
Xunming Ji
Katarina Jood
Mirjam R. Heldner
María Hernández-Pérez
Wayneho Kam
Timothy J. Kleinig
Espen S. Kristoffersen
Ronen R. Leker
Robin Lemmens
Sven Poli
Nilüfer Yeşilot
Mohammad Wasay
Teddy Y. Wu
Marcel Arnold
Lia Lucas-Neto
Saskia Middeldorp
Jukka Putaala
Turgut Tatlisumak
José M. Ferro
Jonathan M. Coutinho
Source :
Frontiers in Neurology, Vol 14 (2023)
Publication Year :
2023
Publisher :
Frontiers Media S.A., 2023.

Abstract

IntroductionCurrent guidelines recommend that patients with cerebral venous thrombosis (CVT) should be treated with vitamin K antagonists (VKAs) for 3–12 months. Direct oral anticoagulants (DOACs), however, are increasingly used in clinical practice. An exploratory randomized controlled trial including 120 patients with CVT suggested that the efficacy and safety profile of dabigatran (a DOAC) is similar to VKAs for the treatment of CVT, but large-scale prospective studies from a real-world setting are lacking.MethodsDOAC-CVT is an international, prospective, observational cohort study comparing DOACs to VKAs for the prevention of recurrent venous thrombotic events after acute CVT. Patients are eligible if they are 18 years or older, have a radiologically confirmed CVT, and have started oral anticoagulant treatment (DOAC or VKA) within 30 days of CVT diagnosis. Patients with an absolute contra-indication for DOACs, such as pregnancy or severe renal insufficiency, are excluded from the study. We aim to recruit at least 500 patients within a three-year recruitment period. The primary endpoint is a composite of recurrent venous thrombosis and major bleeding at 6 months of follow-up. We will calculate an adjusted odds ratio for the primary endpoint using propensity score inverse probability treatment weighting.DiscussionDOAC-CVT will provide real-world data on the comparative efficacy and safety of DOACs versus VKAs for the treatment of CVT.Clinical trial registrationClinicalTrials.gov, NCT04660747.

Details

Language :
English
ISSN :
16642295
Volume :
14
Database :
Directory of Open Access Journals
Journal :
Frontiers in Neurology
Publication Type :
Academic Journal
Accession number :
edsdoj.4ea4e5c957b2402da8fa0e164a4c6cdb
Document Type :
article
Full Text :
https://doi.org/10.3389/fneur.2023.1251581