Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07178925

Follow-up Cohort of Patients With Antiphospholipid Syndrome

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Rouen

Rouen, 76031, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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 outcomes

  1. 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.

    Evaluate the complication rate associated with treatment

  2. 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.

    Look for risk factors associated with thrombotic recurrence

  3. 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.

    Evaluate the mortality rates of this patient population

  4. 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.

    Evaluate the morbidity rates of this patient population

Study contacts

Contact information is provided by the study sponsor or research team.

Sébastien SM MIRANDA, Doctor

CONTACT

[email protected]

02 32 88 90 01 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: ReLaps

Important dates

Study start
2019
Primary completion
2026
Study completion
2031
First posted
Sep 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.