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Direct Oral Anticoagulants for the Treatment of Cerebral Venous Thrombosis

Recruitingn/aAges 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT04660747 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: Patients with cerebral venous thrombosis (CVT) are currently treated with anticoagulants during 3-12 months after diagnosis, to prevent worsening of the CVT and recurrent thrombosis, and to promote venous recanalization. Until recently, patients were generally treated with vitamin K antagonists (VKA). Direct oral anticoagulants (DOACs) are more practical in use than VKA and carry a lower risk of intracranial hemorrhage (ICH) in other conditions. One of the burning clinical questions is whether CVT patients can be safely treated with DOACs instead of VKA. In 2019, the first randomized trial on the safety and efficacy of DOACs in CVT was published (RESPECT-CVT). This exploratory study included 120 patients and the results suggest that DOACs can be safely used to treat CVT. Following RESPECT-CVT, use of DOACs to treat CVT is expected to rise, but given the limited sample size and

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📋 Eligibility rules (as published)
Inclusion Criteria: * Written informed consent for the use of observational data * Age \>18 years at the time of CVT diagnosis * Radiologically confirmed CVT diagnosis (CT-venography, MRI or catheter angiography) * Oral anticoagulant treatment (DOAC or VKA) started within 30 days of CVT diagnosis (patient may initially be treated with heparin) * Inclusion in the study within 90 days of CVT diagnosis Exclusion Criteria: * Anticoagulant treatment at the time of CVT diagnosis * Pregnancy or lactation (post-partum women are eligible if they do not give breast-feeding) * Mechanical heart valve * Severe renal insufficiency (defined as an eGFR \<15 ml/min) * Severe liver disease resulting in clinically relevant coagulopathy
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What it tests

  • Oral anticoagulant
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Where

1 site
Jonathan Coutinho
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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