Follow-up Cohort of Patients With Antiphospholipid Syndrome
Recruiting now
Conditions studied: Antiphospholipid Syndrome (APS)
In brief
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.
Key facts
- Study ID
- NCT07178925
- Run by
- University Hospital, Rouen
- People needed
- 200
- Starts
- 2019-10-16
- Expected to finish
- 2031-10-16
- Last updated by the study team
- 2025-09-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients over 18 years of age and under 75 years of age
- Antiphospholipid syndrome meeting the 2006 Sydney classification
You may not qualify if…
- Patients under the age of 75 or over
- Syndrome not meeting the 2006 Sydney classification
Where it is running
- University hospital of Rouen — Rouen, France (enrolling)
Full record on ClinicalTrials.gov
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