Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous Thromboembolism.
Determine if apixaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if rivaroxaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if apixaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. Determine if rivaroxaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. An exploratory comparison of apixaban versus rivaroxaban for the prevention of clinically relevant bleeding and recurrent Venous Thromboembolism (VTEs) as a secondary objective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3
Will be randomized to receive open label apixaban of 2.5 mg twice daily
Will be randomized to receive open label rivaroxaban of 10mg daily
University of California Irvine Medical Center
Orange, California, United States
Number of Subjects With Clinically Relevant Bleeding Events
Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))
Time frame: Randomization to 12 months
Number of Subjects With Recurrent Venous Thromboembolism (VTE)
Primary efficacy outcome of recurrent VTE
Time frame: Randomization to 12 months
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