Actively Recruiting
Observational Study to Evaluate the Effectiveness of DOACS for Secondary Thrombosis Prevention in Low-risk Thrombotic APS Patients
Led by Infanta Leonor University Hospital · Updated on 2026-01-30
600
Participants Needed
2
Research Sites
160 weeks
Total Duration
On this page
Sponsors
I
Infanta Leonor University Hospital
Lead Sponsor
P
pInvestiga
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Observational Study to Evaluate the Effectiveness of DOACS for Secondary Thrombosis Prevention in Low-risk Thrombotic APS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (≥18 years) diagnosed with thrombotic antiphospholipid syndrome
- Low-risk antiphospholipid syndrome defined by previous venous thrombosis and single or double positive antiphospholipid antibody profile (lupus anticoagulant, anticardiolipin antibodies, and/or anti-beta-2-glycoprotein I antibodies)
- Receiving long-term anticoagulant treatment with direct oral anticoagulants or vitamin K antagonists as part of routine clinical care
- At least 2 weeks of continuous anticoagulant treatment before joining the study
You will not qualify if you...
- Younger than 18 years
- Triple antiphospholipid antibody positivity
- History of arterial thrombosis
- Receiving anticoagulants for reasons other than secondary prevention of venous thrombosis related to antiphospholipid syndrome
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Universitario Infanta Leonor
Madrid, Madrid, Spain, 28031
Actively Recruiting
2
Hospital Universitario Infanta Sofía
Madrid, Madrid, Spain
Actively Recruiting
Research Team
A
Anabel Franco Moreno, MD, PhD
CONTACT
I
Isabel Perales Fraile, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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