Frontiers in Neurology (Sep 2023)
Direct oral anticoagulants for the treatment of cerebral venous thrombosis – a protocol of an international phase IV study
- 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,
- 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,
- Turgut Tatlisumak,
- José M. Ferro,
- Jonathan M. Coutinho
Affiliations
- Anita van de Munckhof
- Department of Neurology, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands
- Mayte Sánchez van Kammen
- Department of Neurology, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands
- Katarzyna Krzywicka
- Department of Neurology, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands
- Sanjith Aaron
- Department of Neurology, Christian Medical College, Vellore, India
- Diana Aguiar de Sousa
- Department of Neurology, Stroke Center, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal
- Florina Antochi
- Department of Neurology, Spitalul Universitar de Urgenţă Bucureşti, Bucharest, Romania
- Antonio Arauz
- Department of Neurology, National Institute of Neurology and Neurosurgery, Mexico City, Mexico
- Miguel A. Barboza
- Department of Neurology, Rafael Angel Calderon Guardia Hospital, San José, Costa Rica
- Adriana B. Conforto
- Department of Neurology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil
- Francesco Dentali
- Department of Neurology, Asst Sette Laghi, Varese, Italy
- Daniel Galdames Contreras
- Stroke Unit, Hospital Clínico de la Universidad de Chile, Santiago, Chile
- Xunming Ji
- 0Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China
- Katarina Jood
- 1Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden
- Katarina Jood
- 2Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden
- Mirjam R. Heldner
- 3Department of Neurology, Inselspital, University Hospital and University of Bern, Bern, Switzerland
- María Hernández-Pérez
- 4Department of Neurology, Hospital Germans Trias i Pujol, Badalona, Spain
- Wayneho Kam
- 5Department of Neurology, Duke University Hospital, Durham, NC, United States
- Timothy J. Kleinig
- 6Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia
- Espen S. Kristoffersen
- 7Department of Neurology, Akershus University Hospital, Nordbyhagen, Norway
- Ronen R. Leker
- 8Department of Neurology, Hadassah – Hebrew University Medical Center, Jerusalem, Israel
- Robin Lemmens
- 9Department of Neurology, UZ Leuven, Leuven, Belgium
- Sven Poli
- 0Department of Neurology, Tübingen University Hospital, Tübingen, Germany
- Nilüfer Yeşilot
- 1Department of Neurology, Istanbul Tip Fakültesi, Istanbul, Turkey
- Mohammad Wasay
- 2Department of Neurology, Aga Khan University, Karachi, Pakistan
- Teddy Y. Wu
- 3Department of Neurology, Christchurch Hospital, Christchurch, New Zealand
- Marcel Arnold
- 3Department of Neurology, Inselspital, University Hospital and University of Bern, Bern, Switzerland
- Lia Lucas-Neto
- 4Department of Neuroradiology, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal
- Saskia Middeldorp
- 5Department of Internal Medicine, Radboud University Medical Center, Nijmegen, Netherlands
- Jukka Putaala
- 6Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
- Turgut Tatlisumak
- 1Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden
- Turgut Tatlisumak
- 2Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden
- José M. Ferro
- 7Centro de Estudos Egas Moniz, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal
- Jonathan M. Coutinho
- Department of Neurology, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands
- DOI
- https://doi.org/10.3389/fneur.2023.1251581
- Journal volume & issue
-
Vol. 14
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.
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