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Observational Study to Evaluate the Effectiveness of DOACS for Secondary Thrombosis Prevention in Low-risk Thrombotic APS Patients
Sponsor: Infanta Leonor University Hospital
Summary
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.
Official title: Real-world Observational Study to Evaluate the Effectiveness and Safety of Direct Oral Anticoagulants Compared With Vitamin K Antagonists for Secondary Thrombosis Prevention in Low-risk Thrombotic Antiphospholipid Syndrome Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2025-12-01
Completion Date
2028-12-31
Last Updated
2026-01-30
Healthy Volunteers
No
Locations (2)
Hospital Universitario Infanta Leonor
Madrid, Madrid, Spain
Hospital Universitario Infanta Sofía
Madrid, Madrid, Spain