OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

This registry will make it possible to collect large-scale data on SAPL patients, particularly those treated with DOACs, in order to better assess the frequency of thrombotic and hemorrhagic events in this population of "non-high-risk" thrombotic SAPL patients treated with DOACs. The results will help refine treatment recommendations and could form the basis of future clinical trials.

In this study, there will be no modification of the usual care and no additional follow-up. Follow-up will be carried out during the patient's usual visits in the context of his or her pathology, the frequency of which will be left to the discretion of the usual physician. No additional consultations/hospitalizations/examinations will be carried out as part of the study. Data normally recorded in the medical record will be collected over a 5-year period, in line with standard patient follow-up.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Incomplete Sydney classification criteria

Presence of a triple antiphospholipid positivity

History of arterial thrombosis

Pregnant, parturient or nursing mother

Trial design

Treatments tested in this trial

  • "non-high risk" thrombotic APS patients treated with DOAC

Treatment groups

500 Participants
are divided into 1 treatment group