Dataset Information

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

ABSTRACT:

Introduction

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.

Methods

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.

Discussion

DOAC-CVT will provide real-world data on the comparative efficacy and safety of DOACs versus VKAs for the treatment of CVT.

Clinical trial registration

ClinicalTrials.gov, NCT04660747.

SUBMITTER: van de Munckhof A

PROVIDER: S-EPMC10539579 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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Publications

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

van de Munckhof Anita A Sánchez van Kammen Mayte M Krzywicka Katarzyna K Aaron Sanjith S Aguiar de Sousa Diana D Antochi Florina F Arauz Antonio A Barboza Miguel A MA Conforto Adriana B AB Dentali Francesco F Galdames Contreras Daniel D Ji Xunming X Jood Katarina K Heldner Mirjam R MR Hernández-Pérez María M Kam Wayneho W Kleinig Timothy J TJ Kristoffersen Espen S ES Leker Ronen R RR Lemmens Robin R Poli Sven S Yeşilot Nilüfer N Wasay Mohammad M Wu Teddy Y TY Arnold Marcel M Lucas-Neto Lia L Middeldorp Saskia S Putaala Jukka J Tatlisumak Turgut T Ferro José M JM Coutinho Jonathan M JM

Frontiers in neurology 20230914

<h4>Introduction</h4>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-wo ...[more]

PMID: 37780701

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Project description:Background and purposeCerebral venous thrombosis causes disability from venous infarct and hemorrhage and potential mortality. Anticoagulation improves survival and disability outcomes, yet direct oral anticoagulants are currently not indicated in cerebral venous thrombosis due to lack of evidence, despite being on the market for nearly a decade. This systematic review will collate evidence of reported safety and efficacy of direct oral anticoagulant therapy in cerebral venous thrombosis.MethodsA search strategy was developed with a research librarian and registered on a protocol database (PROSPERO CRD42017078398). All published studies from MEDLINE and EMBASE up to February 2019 containing patients diagnosed with cerebral venous thrombosis who were treated with a direct oral anticoagulant (dabigatran, rivaroxaban, apixaban, or edoxaban) will be included. A risk of bias analysis will be performed to evaluate quality of studies overall.DiscussionCurrent guidelines in the treatment of cerebral vein thrombosis dating back to 2011 from the American Heart Association/American Stroke Association endorse the utility of anticoagulation for the treatment of cerebral vein thrombosis; however, they did not support the use of direct oral anticoagulants. Updated guidelines from the European Stroke Organization, endorsed by the European Academy of Neurology in 2017, also refute utilization of direct oral anticoagulants due to a lack of evidence. There have been nearly 10 years of experience with direct oral anticoagulants in the treatment of venous thrombosis and prevention of stroke in patients with atrial fibrillation, with purported efficacy and safety in comparison with heparins and vitamin K antagonists. Our goal is to undertake a systematic review to assess the effectiveness and safety of direct oral anticoagulants in patients with cerebral vein thrombosis to help guide clinical decision-making for patients unable to take heparins or vitamin K antagonists and to direct future studies to contribute further to an area of certain evidence-based needs.Systematic review registrationPROSPERO CRD42017078398.

Dataset Information

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

Introduction

Methods

Discussion

Clinical trial registration

Publications

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

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