Actively Recruiting

Age: 18Years - 75Years
All Genders
ID07178925

Follow-up Cohort of Patients With Antiphospholipid Syndrome

Led by University Hospital, Rouen · Updated on 2025-09-17

200

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying Antiphospholipid Syndrome (APS), a rare condition marked by blood clots and pregnancy complications linked to persistent antiphospholipid antibodies. APS can be primary or secondary to autoimmune diseases like lupus and is associated with increased risks of heart attacks, strokes, and artery diseases. Current treatments mainly focus on blood thinning, but new therapies like direct oral anticoagulants and hydroxychloroquine are being explored due to limited data on recurrence rates and treatment safety. This study follows a group of patients diagnosed with APS according to the 2006 Sydney classification. It is an observational cohort study tracking patients retrospectively and prospectively to understand clot recurrence rates, treatment complications, and overall health outcomes. Patients receive standard care with routine follow-up visits every 3 to 12 months over five years, without changes to their usual treatment. Participants will attend consultations at intervals based on their individual situations, with assessments to monitor clot recurrence, complications, risk factors, mortality, and morbidity. The study aims to provide better data on APS progression and treatment safety, helping to design future clinical trials. Follow-up visits and evaluations will not alter the usual disease management, ensuring patient care remains consistent throughout the study.

CONDITIONS

Brief Title

Follow-up Cohort of Patients With Antiphospholipid Syndrome

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients over 18 years of age and under 75 years of age
  • Diagnosis of Antiphospholipid Syndrome meeting the 2006 Sydney classification
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years or older than 75 years
  • Patients with a syndrome not meeting the 2006 Sydney classification

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - Up to 5 years

Participants are followed up in consultation every 3 months, 6 months to 1 year, for up to 5 years depending on the situation to observe thrombotic recurrence, treatment complications, risk factors, mortality, and morbidity.

Consultation visits every 3 months, 6 months, or 1 year depending on the situation

Trial Site Locations

Total: 1 location

1

University hospital of Rouen

Rouen, France, 76031

Actively Recruiting

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Research Team

S

Sébastien SM MIRANDA, Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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