Registry for patients with Antiphospholipid Syndrome treated with direct oral anticoagulants
OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
This study is collecting information from adults with Antiphospholipid Syndrome who have been taking blood thinners called direct oral anticoagulants to see how safe and effective they are for these patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Nancy) |
| Trial ID | NCT04262492 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to collect data on patients with Antiphospholipid Syndrome (APS) who are treated with direct oral anticoagulants (DOACs) like Rivaroxaban. The study will ensure consistency in data collection and provide safety information for non-high-risk APS patients on these medications. Participants must be at least 18 years old and have been on DOACs for a minimum of six months. The registry will help in understanding the long-term effects and safety of DOACs in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with definite APS who have been prescribed DOACs for at least six months.
Not a fit: Patients who do not meet the APS criteria or are under 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance the safety and efficacy of anticoagulant treatments for patients with Antiphospholipid Syndrome.
How similar studies have performed: While this registry approach is not widely tested, similar observational studies have successfully gathered valuable data on anticoagulant treatments in various populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient receiving a comprehensive information about the study, and not opposed to participate * Age ≥ 18 yo * Classification of definite APS according to revised Sapporo-Sydney criteria * Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months Exclusion Criteria: * Incomplete revised Sapporo-Sydney criteria * No data regarding the recurrent thrombosis * Pregnant woman * Age \< 18 yo
Where this trial is running
Nancy
- Stéphane Zuily — Nancy, France (Recruiting)
Study contacts
- Study coordinator: Virginie Dufrost, MD, MSc
- Email: v.dufrost@chru-nancy.Fr
- Phone: +33383157828
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.