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 knowledge about the use of DOACs in patients with low-risk thrombotic antiphospholipid syndrome.
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.
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.
This study includes adult patients with low-risk thrombotic antiphospholipid syndrome managed in routine clinical practice at Internal Medicine units in Spain. Eligible patients have a history of venous thrombotic events and a low-risk antiphospholipid antibody profile and are treated with either direct oral anticoagulants or vitamin K antagonists at the discretion of the treating physician. The study combines retrospective and prospective data collection and does not involve any intervention beyond standard clinical care.
Case-control
Prospective
Not listed
Occurrence of recurrent venous thrombosis
Occurrence of recurrent venous thrombosis during follow-up.
Major or clinically relevant non-major bleeding
Occurrence of major bleeding or clinically relevant non-major bleeding events during follow-up.
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Infanta Leonor University Hospital
Lead sponsor
pInvestiga
Collaborator
