Multicenter, Randomized, Double-blind, Double-dummy, Noninferiority, Phase 3 Study
Patient Population
- Age ≥ 18 years
- Scheduled for total knee replacement surgery
Primary Efficacy outcome
- Adjudicated asymptomatic, or symptomatic DVT, nonfatal PE, and
all-cause death
Secondary Efficacy Outcomes
- Adjudicated symptomatic or asymptomatic proximal DVT, nonfatal
PE, and VTE-related death
Safety Outcomes
- Major bleeding (modified ISTH definition), CRNM bleeding, and a
composite of both
Apixaban 2.5 mg BID
(n = 1528)
(n = 1528)
Enoxaparin 40 mg QD
(n = 1529)
(n = 1529)
Continued prophylaxis
at the discretion of
the investigator
at the discretion of
the investigator
- Apixaban: 12-24 hours after surgery
- Enoxaparin: 40 mg/day started 12 hours before operation
R
N = 3057
Treatment Period
12 ± 2 Days
12 ± 2 Days
Follow-up Period
60 ± 5 Days
60 ± 5 Days
Mandatory Bilateral
Venography
Venography
