OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Apr 8, 2025

Keywords

ClinConnect Summary

The OBServaToIre study is a clinical trial aimed at understanding how patients with Antiphospholipid Syndrome (APS) respond to treatment with Direct Oral Anticoagulants (DOACs). Specifically, the researchers want to gather information on how often patients experience blood clots (thrombotic events) or bleeding events while on these medications. By collecting data from patients over a five-year period during their regular doctor visits, the study hopes to improve treatment recommendations for those considered "non-high-risk" for blood clots.

To be eligible for this study, participants must be at least 18 years old and diagnosed with thrombotic APS, which is a specific type of APS. They should also have either recently stopped or are currently taking a DOAC. Importantly, there won't be any extra appointments or tests required for the participants; their usual medical care will continue as normal, and the information needed for the study will come from their existing medical records. This trial is still in the planning stages and has not started recruiting participants yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Person having received complete information on the organization of the research and not having opposed the use of this data
• • Male or female aged 18 and over;
• • Carrier of a thrombotic APS according to the Sydney classification criteria, regardless of the length of time in the disease
• • Having received a direct oral anticoagulant (DOAC) treatment which is currently discontinued.
• • Or currently treated with DOAC
• Exclusion Criteria:
• • Incomplete Sydney classification criteria
• • Presence of a triple antiphospholipid positivity
• • History of arterial thrombosis
• * Persons referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code:
• • Pregnant, parturient or nursing mother
• • Minor person (not emancipated)
• • Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
• • Person of full age unable to express consent
• • Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1 of the French Public Health Code.
• • Signature of the research participation opposition form