Status:
NOT_YET_RECRUITING
OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Antiphospholipid Syndrome (APS)
Direct Oral Anticoagulants (DOACs)
Eligibility:
All Genders
18+ years
Brief 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...
Detailed Description
Direct oral anticoagulants (DOACs) are indicated as first-line therapy for the prevention of recurrence of venous thromboembolism. The management of APS patients is based on long-term anticoagulation,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2035
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06929182
Start Date
July 1 2025
End Date
July 1 2035
Last Update
April 20 2025
Active Locations (1)
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1
Vall d´Hebron University Hospital
Barcelona, Spain, 08035