January 1, 2015Thrombosis and Haemostasis
Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism
Key result
The EINSTEIN CHOICE study is designed to determine whether two doses of rivaroxaban (20 mg and 10 mg) are superior to aspirin for the prevention of recurrent VTE in 2,850 patients.
Why the study?
Does rivaroxaban (10 mg or 20 mg daily) prevent symptomatic recurrent VTE compared to aspirin in patients with unprovoked VTE who completed 6-12 months of initial anticoagulant therapy?
Population
Anticipated 2,850 patients with unprovoked venous thromboembolism who completed 6-12 months of anticoagulant…
Comparison
Rivaroxaban 20 mg or 10 mg once daily for 12… vs Aspirin 100 mg daily for 12 months.
Design
RCT, randomised, double-blind
Follow-up
12 months
Authors
Discussion
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Implication
Tests rivaroxaban doses vs aspirin for extended VTE prevention; extends prior trials with this large RCT in unprovoked cases.
Study Design
Type
RCT (n=2,850)
Blinding
double-blind
Randomization
randomised
Multicenter
Yes
Structured PICO
Does rivaroxaban (10 mg or 20 mg daily) prevent symptomatic recurrent VTE compared to aspirin in patients with unprovoked VTE who completed 6-12 months of initial anticoagulant therapy?
P
Population
Anticipated 2,850 patients who completed 6-12 months of anticoagulant therapy for an index acute VTE event, planned for 12 months of treatment.
I
Intervention
Rivaroxaban 20 mg or 10 mg once daily for 12 months.
C
Comparator
Aspirin 100 mg daily for 12 months (active-controlled).
O
Outcome
Prevention of symptomatic recurrent VTE.hard clinical
The EINSTEIN CHOICE study protocol outlines a randomized trial to determine if rivaroxaban (10 mg or 20 mg) is superior to aspirin for extended VTE treatment.
Cite This Study
Bauersachs et al. (2015) conducted an RCT in Venous thromboembolism (VTE) (n=2,850). Rivaroxaban vs. Aspirin (100 mg daily) was evaluated on Symptomatic recurrent VTE. The EINSTEIN CHOICE study is designed to determine whether two doses of rivaroxaban (20 mg and 10 mg) are superior to aspirin for the prevention of recurrent VTE in 2,850 patients.