Long-term follow-up of adults with antiphospholipid syndrome
Follow-up Cohort of Patients With Antiphospholipid Syndrome
This project will test how often blood clots come back and which factors affect recurrence in adults with antiphospholipid syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen) |
| Trial ID | NCT07178925 on ClinicalTrials.gov |
What this trial studies
This single-center cohort combines retrospective chart review with prospective follow-up of adults meeting the 2006 Sydney criteria for antiphospholipid syndrome at the University Hospital of Rouen. The primary objective is to determine the rate of thrombotic recurrence (arterial and venous) in this population at our center. Secondary objectives include identifying clinical and treatment-related risk factors for recurrence, evaluating long-term treatment safety, and documenting overall morbidity and mortality. Results will be used to refine estimates of recurrence risk and to inform sample-size planning for future therapeutic trials.
Who should consider this trial
Good fit: Adults aged 18–75 with antiphospholipid syndrome confirmed by the 2006 Sydney classification are the intended participants.
Not a fit: People under 18, over 75, or without antiphospholipid syndrome by the 2006 Sydney criteria are not eligible and therefore would not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide more accurate recurrence rates and identify risk factors that help guide treatment decisions and the design of future trials.
How similar studies have performed: Previous observational cohorts have reported recurrence rates around 5% per year, but those studies are older and heterogeneous, so findings are only partially consistent and not definitive.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rouen
- University hospital of Rouen — Rouen, France (Recruiting)
Study contacts
- Study coordinator: Sébastien SM MIRANDA, Doctor
- Email: Sebastien.Miranda@chu-rouen.fr
- Phone: 02 32 88 90 01
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.