Antiphospholipid Syndrome (APS)
Conditions
Keywords
thrombotic recurrence rate, risk factors, treatment tolerance
Brief 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.
Detailed description
This trial is a retrospective and prospective cohort epidemiological study whose primary objective is to determine the rate of thrombotic recurrence in our center. Secondary objectives are to determine the risk factors associated with recurrence, assess the safety of long-term treatment in this population, and evaluate the overall morbidity and mortality of this rare disease. A better understanding of thrombotic recurrence is essential to calculate realistic population sizes for future therapeutic trials.
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.
Sponsors
University Hospital, Rouen
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients over 18 years of age and under 75 years of age * Antiphospholipid syndrome meeting the 2006 Sydney classification
Exclusion criteria
* Patients under the age of 75 or over * Syndrome not meeting the 2006 Sydney classification
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thrombotic recurrence rate | Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease. | Evaluate the complication rate associated with treatment |
| Risk factors associated | Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease. | Look for risk factors associated with thrombotic recurrence |
| Mortality rates | Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease. | Evaluate the mortality rates of this patient population |
| Morbidity rates | Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease. | Evaluate the morbidity rates of this patient population |
Countries
France
Contacts
Primary ContactSébastien SM MIRANDA, Doctor
Outcome results
None listed