Clinical Trial

OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs

Study acronym: OBSTINATE 2
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-08.
Trial Details
NCT Number NCT06929182
Lead Sponsor Central Hospital, Nancy, France
Conditions Antiphospholipid Syndrome (APS), Direct Oral Anticoagulants (DOACs), Thrombotic and Bleeding Events, Safety
Enrollment 500 participants
Start Date 2025-07-01
Primary Completion 2035-07-01 (estimated)
Study Completion 2035-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-20