NCT07178925 Follow-up Cohort of Patients With Antiphospholipid Syndrome
| NCT ID | NCT07178925 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Antiphospholipid Syndrome (APS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-10-16 |
| Primary Completion | 2026-10-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2019-10-16 with a primary completion date of 2026-10-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07178925 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Antiphospholipid Syndrome (APS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07178925 currently recruiting?
Yes, NCT07178925 is actively recruiting participants. Contact the research team at Sebastien.Miranda@chu-rouen.fr for enrollment information.
Where is the NCT07178925 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT07178925 clinical trial?
NCT07178925 is sponsored by University Hospital, Rouen. The trial plans to enroll 200 participants.