Anticoagulants Causing Adverse Effects in Therapeutic Use, Antiphospholipid Syndrome, Thrombosis
Conditions
Keywords
antiphospholipid syndrome, direct oral anticoagulants
Brief summary
This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.
Interventions
DRUGRivaroxaban
Rivaroxaban 10 mg or 15 mg or 20 mg OD Dabigatran 110 mg or 150 mg BID Apixaban 2.5 mg or 5 mg or 10 mg BID
Sponsors
Stéphane Zuily
International Society on Thrombosis and Haemostasis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Recurrent Thrombosis | 6 months | Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Bleeding | 6 months | Rate of Bleeding either severe or major or clinically relevant non-major bleeding according to ISTH classification |
| Rate of Non-Criteria Manifestations | 6 months | Rate of Non-Criteria Manifestations according to Sydney criteria |
| Adherence to treatment | 6 months | Rate of patients who have a good adherence to oral anticoagulants assessed by the Girerd questionnaire |
Countries
France
Contacts
CONTACTVirginie Dufrost, MD, MSc
Outcome results
None listed