RecruitingNCT07178925

Follow-up Cohort of Patients With Antiphospholipid Syndrome


Sponsor

University Hospital, Rouen

Enrollment

200 participants

Start Date

Oct 16, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

  • Adult patients over 18 years of age and under 75 years of age
  • Antiphospholipid syndrome meeting the 2006 Sydney classification

Exclusion Criteria2

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

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Interventions

OTHERStudy of Antiphospholipid Syndrome responding to the Sydney classification of 2006

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.


Locations(1)

University hospital of Rouen

Rouen, France

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NCT07178925


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