Actively Recruiting
Led by Infanta Leonor University Hospital · Updated on 2026-01-30
600
Participants Needed
2
Research Sites
N/A
Total Duration
I
Infanta Leonor University Hospital
Lead Sponsor
P
pInvestiga
Collaborating Sponsor
Researchers are evaluating the safety and effectiveness of direct oral anticoagulants (DOACs) compared with vitamin K antagonists (VKAs) for preventing blood clots in patients with low-risk thrombotic antiphospholipid syndrome (APS). APS is an autoimmune disorder that increases the risk of blood clots. While VKAs have been the standard treatment, DOACs are being used more, despite limited evidence for this group of patients. This observational study aims to provide real-world information to guide treatment decisions in these patients. The study observes adult patients diagnosed with low-risk thrombotic APS who have previously had venous thrombosis and are treated with either DOACs or VKAs as part of their regular care. Treatment decisions are made by the patients' doctors, and the study does not intervene in treatment choices. Participants must have been on continuous anticoagulant treatment for at least two weeks before joining the study. Participants will be followed to monitor the occurrence of new venous thrombosis events over 24 months. Researchers will also assess major or clinically relevant bleeding, overall mortality, cardiovascular-related deaths, and quality of life related to anticoagulant treatment using the Anti-Clot Treatment Scale (ACTS). The study is carried out in internal medicine units and aims to reflect routine clinical practice in patients with low-risk thrombotic APS.
CONDITIONS
Observational Study to Evaluate the Effectiveness of DOACS for Secondary Thrombosis Prevention in Low-risk Thrombotic APS Patients
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who undergo routine anticoagulant treatment with direct oral anticoagulants or vitamin K antagonists for secondary prevention of venous thrombosis are observed under routine clinical practice conditions.
Follow-up visits as per routine clinical care
Total: 2 locations
1
Hospital Universitario Infanta Leonor
Madrid, Madrid, Spain, 28031
Actively Recruiting
2
Hospital Universitario Infanta Sofía
Madrid, Madrid, Spain
Actively Recruiting
A
Anabel Franco Moreno, MD, PhD
I
Isabel Perales Fraile, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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I Perales Fraile, M Martín Asenjo, C L de Ancos Aracil...
https://pubmed.ncbi.nlm.nih.gov/42067060