Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis (DOAC-CVT)
About the study
DOAC-CVT is an international, prospective, observational cohort study investigating the safety and efficacy of direct oral anticoagulants (DOACs) compared to vitamin K antagonists (VKAs) in the treatment of cerebral venous thrombosis.
Patients may be included if they fulfill the following criteria:
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Age >18 years at the time of CVT diagnosis
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Radiologically confirmed CVT diagnosis (CT-venography, MRI or catheter angiography)
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Oral anticoagulant treatment (DOAC or VKA) started within 30 days of CVT diagnosis (patient may initially be treated with heparin)
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Informed consent for the use of coded data if required by local law.
Exclusion criteria are:
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Anticoagulant treatment at the time of CVT diagnosis
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Absolute contra-indication for use of DOACs:
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Pregnancy or lactation (post-partum women are eligible if they do not give breast-feeding)
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Mechanical heart valve
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Severe renal insufficiency (defined as an eGFR <15 ml/min)
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Severe liver disease resulting in clinically relevant coagulopathy
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Primary endpoint: symptomatic venous thromboembolism and major bleeding events at 6 months.
For more details about the study, please see the published Study Protocol Paper: Frontiers | Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis (DOAC-CVT) -A Protocol of an International Phase IV Study (frontiersin.org)
Status of the study
The patients recruited until January 15, 2024 (619 patients from 23 countries) will be included in the primary data analysis. Follow-up data of these patients are currently being collected. The primary and major secondary endpoints at 6 months will be presented at the World Stroke Congress 2024.
In addition, we will continue patient recruitment in an extension of the study until January 2026. The aims of the extension study are: 1. to have a larger sample size for the primary endpoint; 2. to add new research questions focused on outcomes after CVT; 3. to further strengthen global collaboration.
The Ethical Review Committee of Amsterdam UMC reviewed the revised study protocol and provided a renewed waiver for formal approval ethical approval in accordance with the Dutch law. If you would like to participate in this research project, please e-mail the project leader Dr. Jonathan Coutinho.
Data collection
Please click on the button below to access the electronic database (Castor EDC). Access to the online CRF must be provided by the study coordinators.