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

Key facts

Who runs it
Infanta Leonor University Hospital
Where
Spain2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
600 people, planned
Started
1 Dec 2025
Expected to end
31 Dec 2028
Type of study
Observational, 2 groups
Record updated
30 January 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • Triple antiphospholipid antibody positivity
  • History of arterial thrombosis
  • Anticoagulation for indications other than secondary prevention of venous thrombosis related to antiphospholipid syndrome
  • Age <18 years

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Patients with low-risk thrombotic antiphospholipid syndrome receiving direct oral anticoagulants

    Patients with low-risk thrombotic antiphospholipid syndrome receiving direct oral anticoagulants for secondary prevention of venous thrombosis according to routine clinical practice. Treatment choice is made by the treating physician, with no intervention

  • Patients with low-risk thrombotic antiphospholipid syndrome receiving vitamin K antagonist

    Patients with low-risk thrombotic antiphospholipid syndrome receiving vitamin K antagonists for secondary prevention of venous thrombosis according to routine clinical practice. Treatment choice is made by the treating physician, with no intervention

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Publications
Record updated
30 January 2026