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

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机构： [1]Department of Neurology, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands, [2]Department of Neurology, Christian Medical College, Vellore, India, [3]Department of Neurology, Stroke Center, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal, [4]Department of Neurology, Spitalul Universitar de Urgenţă Bucureşti, Bucharest, Romania, [5]Department of Neurology, National Institute of Neurology and Neurosurgery, Mexico City, Mexico, [6]Department of Neurology, Rafael Angel Calderon Guardia Hospital, San José, Costa Rica, [7]Department of Neurology, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil, [8]Department of Neurology, Asst Sette Laghi, Varese, Italy, [9]Stroke Unit, Hospital Clínico de la Universidad de Chile, Santiago, Chile, [10]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China, [11]Department of Neurology, Sahlgrenska University Hospital, Gothenburg, Sweden, [12]Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden, [13]Department of Neurology, Inselspital, University Hospital and University of Bern, Bern, Switzerland, [14]Department of Neurology, Hospital Germans Trias i Pujol, Badalona, Spain, [15]Department of Neurology, Duke University Hospital, Durham, NC, United States, [16]Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia, [17]Department of Neurology, Akershus University Hospital, Nordbyhagen, Norway, [18]Department of Neurology, Hadassah – Hebrew University Medical Center, Jerusalem, Israel, [19]Department of Neurology, UZ Leuven, Leuven, Belgium, [20]Department of Neurology, Tübingen University Hospital, Tübingen, Germany, [21]Department of Neurology, Istanbul Tip Fakültesi, Istanbul, Turkey, [22]Department of Neurology, Aga Khan University, Karachi, Pakistan, [23]Department of Neurology, Christchurch Hospital, Christchurch, New Zealand, [24]Department of Neuroradiology, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal, [25]Department of Internal Medicine, Radboud University Medical Center, Nijmegen, Netherlands, [26]Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland, [27]Centro de Estudos Egas Moniz, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal

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关键词： cerebral venous thrombosis anticoagulants DOAC vitamin K antagonist treatment

摘要：

Current 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.DOAC-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.DOAC-CVT will provide real-world data on the comparative efficacy and safety of DOACs versus VKAs for the treatment of CVT.ClinicalTrials.gov, NCT04660747.Copyright © 2023 van de Munckhof, Sánchez van Kammen, Krzywicka, Aaron, Aguiar de Sousa, Antochi, Arauz, Barboza, Conforto, Dentali, Galdames Contreras, Ji, Jood, Heldner, Hernández-Pérez, Kam, Kleinig, Kristoffersen, Leker, Lemmens, Poli, Yeşilot, Wasay, Wu, Arnold, Lucas-Neto, Middeldorp, Putaala, Tatlisumak, Ferro and Coutinho.

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出版当年[2022]版：

大类 | 3 区医学

小类 | 3 区神经科学 3 区临床神经病学

最新[2023]版：

大类 | 3 区医学

小类 | 3 区临床神经病学 3 区神经科学

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出版当年[2021]版：

Q2 CLINICAL NEUROLOGY Q2 NEUROSCIENCES

最新[2023]版：

Q2 CLINICAL NEUROLOGY Q3 NEUROSCIENCES

影响因子： 2.7 最新[2023版] 3.3 最新五年平均 4.086 出版当年[2021版] 4.321 出版当年五年平均 4.003 出版前一年[2020版] 3.4 出版后一年[2022版]

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第一作者机构： [1]Department of Neurology, Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands,

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

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