Consented patients undergoing elective total hip and total knee arthroplasty will be randomized to receive either aspirin alone or aspirin and rivaroxaban for prevention of venous thromboembolism.
Aspirin and rivaroxaban prevent venous thromboembolism (VTE) via different mechanisms. Aspirin is significantly cheaper than rivaroxaban. Aspirin in combination with rivaroxaban was shown to be safe and efficacious in a non-inferiority trial (EPCATII) when compared to rivaroxaban alone. This study will assess if aspirin alone is non-inferior to rivaroxaban and aspirin in the prevention of venous thromboembolism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
5,400
Starting post op, rivaroxaban (5 days) followed by aspirin (9 days for TKA; 30 days for THA)
Starting post op, aspirin for 9 days for TKA and 30 days for THA
Queen Elizabeth II HSC
Halifax, Nova Scotia, Canada
RECRUITINGVenous thromboembolism
symptomatic proximal deep vein thrombosis or pulmonary embolism
Time frame: 90 days
Bleeding
major and clinically relevant, non-major bleeds
Time frame: 90 days
Survival
all cause death
Time frame: 90 days
Cost-effectiveness
quantitatively describe the costs of symptomatic thromboembolism events and major bleeding episodes
Time frame: 90 days
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