Antiphospholipid Syndrome (APS)DOACS-APSNCT07372170
Observational Study to Evaluate the Effectiveness of DOACS for Secondary Thrombosis Prevention in Low-risk Thrombotic APS Patients
An observational study of Antiphospholipid Syndrome (APS) and Venous Thrombosis (Disorder), run by Infanta Leonor University Hospital at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiphospholipid Syndrome (APS), Venous Thrombosis (Disorder), Thrombophilia
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Dec 2025to 31 Dec 2028
- How long will I take part?
- 36 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes adult patients with low-risk thrombotic antiphospholipid syndrome managed in routine clinical practice at Internal Medicine units in Spain. Eligible patients have a history of venous thrombotic events and a low-risk antiphospholipid antibody profile and are treated with either direct oral anticoagulants or vitamin K antagonists at the discretion of the treating physician. The study combines retrospective and prospective data collection and does not involve any intervention beyond standard clinical care.
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Isabel Perales Fraile, MD contact
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Infanta Leonor
Madrid, Madrid, 28031
Anabel Franco-Moreno, MD, PhD, 686102661, afranco278@hotmail.com
- Recruiting
Hospital Universitario Infanta Sofía
Madrid, Madrid
Isabel Perales Fraile, MD, isabelperalesf@gmail.com
About this study
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
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.
Read more
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.
Read the detailed description
Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by the occurrence of arterial, venous, or small-vessel thrombosis in the presence of persistent antiphospholipid antibodies. Patients with thrombotic APS have a high risk of recurrent thrombosis and require long-term anticoagulation. Vitamin K antagonists (VKAs) have traditionally been the treatment of choice in this population.
Direct oral anticoagulants (DOACs) have demonstrated efficacy and safety in other clinical settings, such as venous thromboembolism and non-valvular atrial fibrillation. However, their use in APS remains controversial following randomized clinical trials that showed an increased risk of arterial thrombotic events, particularly in patients with high-risk serological profiles.
Current clinical guidelines suggest that DOACs may be considered in selected patients with low-risk thrombotic APS, defined by venous thrombosis and the absence of triple antiphospholipid antibody positivity. Nevertheless, evidence supporting their use in this specific subgroup is limited.
This observational, analytical, ambispective (retrospective and prospective) study aims to evaluate the effectiveness and safety of DOACs compared with VKAs in patients with low-risk thrombotic APS under routine clinical practice conditions.
Adult patients with a diagnosis of low-risk thrombotic APS who are receiving treatment with DOACs or VKAs at the time of inclusion will be eligible. Anticoagulant therapy will be prescribed at the discretion of the treating physician, with no intervention by the study protocol.
The primary objective is to assess a combined effectiveness and safety endpoint, including thrombotic recurrence and major or clinically relevant bleeding. Secondary objectives include all-cause mortality, cardiovascular mortality, and treatment-related quality of life assessed using the Anti-Clot Treatment Scale (ACTS).
The study will be conducted in Internal Medicine units across Spain and is expected to provide relevant real-world evidence to support clinical decision-making in the anticoagulant management of patients with low-risk thrombotic antiphospholipid syndrome.
- Keywords
- Direct oral anticoagulants, Vitamin K antagonists, Low-risk antiphospholipid syndrome, Secondary thrombosis prevention, Real-world study, Observational study, Venous Thrombosis, Antiphospholipid Antibody Profile
- Medical subject headings
- Antiphospholipid Syndrome, Venous Thrombosis, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of recurrent venous thrombosis
Occurrence of recurrent venous thrombosis during follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antiphospholipid Syndrome (APS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Infanta Leonor University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- pInvestiga
- Responsible party
- Principal investigator, Anabel Franco Moreno, Infanta Leonor University Hospital
- Investigators
- Anabel Franco-Moreno, MD, PhD, Principal investigator, Sociedad Española De Medicina Interna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372170
- Sponsor's protocol ID
- DOACS-APS
- Acronym
- DOACS-APS
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in publications arising from this study will be made available upon reasonable request. Data will be shared after publication of the primary results, subject to approval by the study investigators and in accordance with applicable ethical and legal requirements. Requests must include a methodologically sound research proposal, and data will be provided under a data sharing agreement to ensure participant confidentiality.
Publications
Perales Fraile I, Martin Asenjo M, de Ancos Aracil CL, Torres Macho J, Saez Comet L, Martin Cascon M, Alijotas Reig J, Gonzalez Garcia A, Franco Moreno A. Real-world observational study to evaluate the effectiveness and safety of direct oral anticoagulants compared with vitamin K antagonists for secondary venous thrombosis prevention in low-risk thrombotic antiphospholipid syndrome patients: DOACS-APS protocol. Rev Clin Esp (Barc). 2026 Jun-Jul;226(6):502564. doi: 10.1016/j.rceng.2026.502564. Epub 2026 Apr 29.
PubMed 42067060