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Observational Study to Evaluate the Effectiveness of DOACS for Secondary Thrombosis Prevention in Low-risk Thrombotic APS Patients

Recruitingn/aAges 18 Years - anyAllInfanta Leonor University Hospital
NCT07372170 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is an observational study designed to evaluate the effectiveness and safety of direct oral anticoagulants (DOACs) compared with vitamin K antagonists (VKAs) for the secondary prevention of thrombosis in patients with low-risk thrombotic antiphospholipid syndrome. Antiphospholipid syndrome is an autoimmune disorder associated with an increased risk of thrombotic events. Although VKAs have traditionally been the standard treatment, DOACs are increasingly used in clinical practice in selected patients, despite limited evidence in this setting. This study includes patients with previous venous thrombosis and a low-risk serological profile who are treated with either DOACs or VKAs according to routine clinical practice. The primary objective is to compare thrombotic recurrence and bleeding events between both treatment strategies. The results of this study will contribute to improving

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults (≥18 years) with a diagnosis of thrombotic antiphospholipid syndrome. * Low-risk antiphospholipid syndrome defined by previous venous thrombosis and a single or double positive antiphospholipid antibody profile (lupus anticoagulant, anticardiolipin antibodies, and/or anti-beta-2-glycoprotein I antibodies). * Patients receiving long-term anticoagulant treatment with direct oral anticoagulants or vitamin K antagonists according to routine clinical practice. * At least 2 weeks of continuous anticoagulant treatment before study inclusion. Exclusion Criteria: * Age \<18 years. * Triple antiphospholipid antibody positivity. * History of arterial thrombosis. * Anticoagulation for indications other than secondary prevention of venous thrombosis related to antiphospholipid syndrome.
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What it tests

  • Not listed
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Where

2 sites
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario Infanta Sofía
Madrid, Spain
🤝 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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