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

Recruiting now

Conditions studied: Antiphospholipid Syndrome (APS), Venous Thrombosis (Disorder), Thrombophilia

In brief

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.

Key facts

Study ID

NCT07372170

Run by

Infanta Leonor University Hospital

People needed

600

Starts

2025-12-01

Expected to finish

2028-12-31

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Universitario Infanta Leonor — Madrid, Madrid, Spain (enrolling)
• Hospital Universitario Infanta Sofía — Madrid, Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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