About this trial
This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Incomplete revised Sapporo-Sydney criteria
No data regarding the recurrent thrombosis
Pregnant woman
Age < 18 yo
Trial population
Thrombotic APS patients according to revised Sapporo-Sydney criteria
Trial design
Cohort
Prospective
Treatments tested in this trial
Rivaroxaban
DrugRivaroxaban 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
Treatment groups
Trial outcomes
Primary outcomes
Rate of Recurrent Thrombosis
Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam
Secondary outcomes
Rate of Bleeding
Rate of Bleeding either severe or major or clinically relevant non-major bleeding according to ISTH classification
Rate of Non-Criteria Manifestations
Rate of Non-Criteria Manifestations according to Sydney criteria
Adherence to treatment
Rate of patients who have a good adherence to oral anticoagulants assessed by the Girerd questionnaire
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Stéphane Zuily
Lead sponsor
Central Hospital, Nancy, France
Sponsor institution
International Society on Thrombosis and Haemostasis
Collaborator