DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study

Not yet recruitingOBSERVATIONAL
Enrollment

310

Participants

Timeline

Start Date

September 15, 2025

Primary Completion Date

September 15, 2031

Study Completion Date

September 15, 2031

Conditions
Antiphospholipid Syndrome (APS)Cohort StudyThrombotic and Bleeding Events
Interventions
BIOLOGICAL

Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml)

"At inclusion, the blood sample is used to perform thrombin generation tests (activated protein C resistance profile and ratio), classical and innovative aPL assays centrally to limit the fluctuation inherent in the tests used and enable comparison between patients, immunothrombosis markers: circulating neutrophil extracellular traps (NETs) assay, sTREM-1 assay~In the event of recurrence, blood sampling can be used to confirm compliance with treatment by measuring the anti Xa activity of the drug or INR"

BEHAVIORAL

Completion of a questionnaire on compliance with anticoagulant treatment

The Girerd questionnaire (6 questions) will be proposed to patients in order to estimate the degree of compliance with AODs and VKAs at inclusion and at each follow-up visit for the duration of their participation in the study.

BEHAVIORAL

Completion of a questionnaire on satisfaction with treatment anticoagulant

The ACTS questionnaire (15 questions) will be proposed to them in order to estimate their satisfaction with their anticoagulant treatment (AOD or AVK) at inclusion and at each follow-up visit for the duration of their participation in the study.

Trial Locations (13)

21079

CHU de Dijon, Dijon

25030

CHU de Besançon, Besançon

29200

CHU de Brest, Brest

42270

CHU de Saint Etienne, Saint-Priest-en-Jarez

44800

CHU de Nantes, Nantes

51100

CHU de Reims, Reims

54500

Central Hospital, Nancy, France, Vandœuvre-lès-Nancy

57000

Hôpital Robert Schuman, UNEOS, Metz

67091

CHU de Strasbourg - Hôpital civil, Strasbourg

68100

CH de Mulhouse, Mulhouse

69003

CHU de Lyon, Lyon

75010

Hôpital Lariboisière - APHP, Paris

80054

CHU d'Amiens, Amiens

All Listed Sponsors
lead

Central Hospital, Nancy, France

OTHER