Rivaroxaban for Patients With Antiphospholipid Syndrome
Status:
Completed
Trial end date:
2017-12-31
Target enrollment:
Participant gender:
Summary
Long-term anticoagulation is widely used for secondary thromboprophylaxis in the
antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently
anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have
unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment.
Rivaroxaban, an orally active direct factor Xa inhibitor, has been shown to be effective and
safe compared with warfarin for the treatment of venous thromboembolism and non valvular
atrial fibrillation in major RCTs. No studies had been published in APS.The aim of the study
is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis
in patients with APS compared with acenocoumarol
Phase:
Phase 3
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute