Follow-up Cohort of Patients With Antiphospholipid Syndrome

NCT ID: NCT07178925

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2031-10-16

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.

Conditions

Antiphospholipid Syndrome (APS)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University hospital of Rouen

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sébastien SM MIRANDA, Doctor

Role: CONTACT

Sebastien.Miranda@chu-rouen.fr

02 32 88 90 01 ext. +33

Other Identifiers

2018-A02845-50

Identifier Type: OTHER

Identifier Source: secondary_id

2018/353/OB

Identifier Type: -

Identifier Source: org_study_id