Follow-up Cohort of Patients With Antiphospholipid Syndrome

NCT07178925 | Recruiting

• 2 other identifiers: 2018/353/OB2018-A02845-50
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Antiphospholipid Syndrome (APS)

Keywords

thrombotic recurrence rate; risk factors; treatment tolerance

Outcome Measures

Primary Outcomes (1)

• Thrombotic recurrence rate

  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.

  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 Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Interventions

Study of Antiphospholipid Syndrome responding to the Sydney classification of 2006 OTHER

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients monitored for Antiphospholipid Syndrome (APLS) in the internal medicine department

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University hospital of Rouen

Rouen, 76031, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A collection of biological samples will be created during this research protocol to enable the subsequent identification of endothelial, oxidative stress and coagulation parameters in these patients.

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Sébastien SM MIRANDA, Doctor

CONTACT

02 32 88 90 01; Sebastien.Miranda@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: October 16, 2019
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): October 16, 2031
• Last Updated: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)