About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients over 18 years of age and under 75 years of age

Antiphospholipid syndrome meeting the 2006 Sydney classification

Disqualifiers

Patients under the age of 75 or over

Syndrome not meeting the 2006 Sydney classification

Trial population

Patients monitored for Antiphospholipid Syndrome (APLS) in the internal medicine department

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Study of Antiphospholipid Syndrome responding to the Sydney classification of 2006
Other intervention
The main objective of the research is to define the thrombotic recurrence rate in our cohort of patients followed for APS in the internal medicine department, to evaluate the complication rate associated with treatment, to search for risk factors associated with thrombotic recurrence and to define the mortality and morbidity rates of this patient population.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Thrombotic recurrence rate

The main objective of the research is to define the thrombotic recurrence rate in our cohort of patients followed for APS in the internal medicine department.

Time frame