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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
81
University of Alberta Hospital
Edmonton, Alberta, Canada
Queen Elizabeth II Hospital
Halifax, Nova Scotia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Feasibility of identification for enrolment
The investigators define success as the ability to identify 150 eligible patients at 6 clinical centres over 18 months.
Time frame: 18 months
Feasibility of Consent
The investigators define success as a consent rate of 90% (thus, if we identify 150 patients, at least 135 will provide consent).
Time frame: 18 months
Compliance
The investigators define success as a patient missing fewer than 5% of days with pill administrations, as measured by pill counts.
Time frame: Minimum of one year for all subjects
Bleeding
The investigators will collect and report the rates of minor bleeding (clinically apparent bleeding that does not meet the criteria for major), and major and fatal bleeding. Major bleeding will be defined by International Society of Thrombosis and Hemostasis criteria.
Time frame: Minimum of one year for all subjects
Thrombosis
The investigators will collect and report the rates of objectively-confirmed venous and arterial thrombosis.
Time frame: Minimum of one year for all subjects
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