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

NCT07372170 | Recruiting DMC

• 1 other identifier: DOACS-APS
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief 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. 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

Venous Thrombosis (Disorder); Thrombophilia; Antiphospholipid Syndrome (APS)

Keywords

Direct oral anticoagulants; Vitamin K antagonists; Low-risk antiphospholipid syndrome; Secondary thrombosis prevention; Real-world study; Observational study; Venous Thrombosis; Antiphospholipid Antibody Profile

Outcome Measures

Primary Outcomes (1)

• Occurrence of recurrent venous thrombosis

  Occurrence of recurrent venous thrombosis during follow-up.

  24 months

Other Outcomes (1)

• Major or clinically relevant non-major bleeding

  24 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

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.

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.

Sponsors & Collaborators

• Infanta Leonor University Hospital: lead
• pInvestiga: collaborator

Study Sites (2)

Hospital Universitario Infanta Leonor

Madrid, Madrid, 28031, Spain

RECRUITING

Hospital Universitario Infanta Sofía

Madrid, Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Antiphospholipid Syndrome; Venous Thrombosis; Thrombophilia

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Anabel Franco-Moreno, MD, PhD

  Sociedad Española De Medicina Interna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anabel Franco Moreno, MD, PhD

CONTACT

+34686102661; afranco278@hotmail.com

Isabel Perales Fraile, MD

CONTACT

isabelperalesf@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

ES (2)