Follow-up Cohort of Patients With Antiphospholipid Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Study of Antiphospholipid Syndrome responding to the Sydney classification of 2006.
- Who it may be relevant to
- Registry conditions: Antiphospholipid Syndrome (APS). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Study 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.
Primary outcome measures
- Thrombotic recurrence rate [Time frame: 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.]
Secondary outcome measures (4)
- Complication rate [Time frame: 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.]
- Risk factors associated [Time frame: 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.]
- Mortality rates [Time frame: 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.]
- Morbidity rates [Time frame: 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- University hospital of Rouen — Rouen
Identifiers
NCT: NCT07178925 · 2018/353/OB · 2018-A02845-50