Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT07178925

Follow-up Cohort of Patients With Antiphospholipid Syndrome

Led by University Hospital, Rouen · Updated on 2025-09-17

200

Participants Needed

1

Research Sites

626 weeks

Total Duration

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AI-Summary

What this Trial Is About

Antiphospholipid syndrome (APLS) is a rare pathology characterized by the association of thrombotic (arterial, venous) or obstetric clinical manifestations and the persistent presence at least twelve weeks apart of antiphospholipid antibodies (APL). It is also accompanied by accelerated atherosclerosis responsible for an increased incidence of myocardial infarction, peripheral arterial disease and stroke explaining the high cardiovascular morbidity and mortality of these patients. APS can be isolated (primary) or integrated into an autoimmune pathology such as systemic lupus erythematosus (SLE), thus defining secondary APS. Current treatment is based on anticoagulation. Currently, epidemiological data that have evaluated recurrences have estimated a rate of 5% per year. However, these studies are old and due to the significant heterogeneity of patients included in this registry, it seems that these figures are not in agreement with clinical reality. Furthermore, several new therapeutic developments have emerged in the field of anticoagulation with the marketing of DOACs, making the EUROPHOSPHOLIPIDE data questionable. Currently, there are no clinical studies to justify the use of DOACs in this indication, but several patients have received these drugs due to intolerance or refusal of vitamin K antagonists. The other therapeutic innovation compared to the data from the EUROPHOSPHOLIPIDE cohort is the increasing use of hydroxychloroquine in clinical practice in patients with primary APS. A trial (APLAQUINE) is currently underway in our department which aims to study the endothelial protective effect of this treatment in patients with primary APS.

CONDITIONS

Official Title

Follow-up Cohort of Patients With Antiphospholipid Syndrome

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients over 18 years of age and under 75 years of age
  • Antiphospholipid syndrome meeting the 2006 Sydney classification
Not Eligible

You will not qualify if you...

  • Patients under 18 years or over 75 years of age
  • Syndrome not meeting the 2006 Sydney classification

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University hospital of Rouen

Rouen, France, 76031

Actively Recruiting

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Research Team

S

Sébastien SM MIRANDA, Doctor

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

0

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