Rivaroxaban for Antiphospholipid Antibody Syndrome
Status:
Completed
Trial end date:
2017-09-30
Target enrollment:
Participant gender:
Summary
The antiphospholipid antibody syndrome (APS) is a syndrome associated with excessive blood
clotting (thrombosis). APS is among the most common cause of heart attack and stroke in
patients under the age of 50 and is particularly prevalent in patients with autoimmune
conditions. Patients with APS and prior thrombosis require lifelong anticoagulant therapy to
prevent recurrent clots; such therapy is currently provided with warfarin. Warfarin requires
frequent bloodwork monitoring, and many medications or foods can alter its effect, which can
put people either at increased risk for clotting or bleeding. Rivaroxaban is a new mediation
that prevents blood clots that does not require bloodwork monitoring and that has fewer
interactions. This study is a pilot feasibility study which will: 1) examine our ability to
identify 150 eligible APS patients; 2) measure our ability to obtain consent from 135 of
these patients; and 3) test our hypothesis that we can obtain 95% compliance with daily
rivaroxaban administration. The investigators propose to treat eligible patients with
rivaroxaban 20 mg once daily. Patients will be followed for a minimum of one year and their
rates of bleeding and thrombosis will be monitored as secondary outcome measures.
Phase:
Phase 4
Details
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Collaborators:
Bayer Hamilton Health Sciences Corporation Heart and Stroke Foundation of Canada Jewish General Hospital Queen Elizabeth II Health Sciences Centre The Ottawa Hospital University of Alberta