A randomized, multicenter, double-blind, double-dummy phase III study
Patient Population (N = 3195)
- Undergoing elective knee
replacement surgery
Apixaban 2.5 mg orally twice daily
initiated 12 to 24 hours post surgery
initiated 12 to 24 hours post surgery
Enoxaparin 30 mg subcutaneously twice daily
initiated 12 to 24 hours after surgery
initiated 12 to 24 hours after surgery
Randomized
Double-blind
Double-blind
n = 1599
n = 1596
Study regions included North America, Europe, Latin
America, and Asia/Pacific Islands
America, and Asia/Pacific Islands
Treatment duration: 10 – 14 days
(Mean ± SD: 11.7 ± 2.5 days ELIQUIS,
11.6 ± 2.5 days enoxaparin)
(Mean ± SD: 11.7 ± 2.5 days ELIQUIS,
11.6 ± 2.5 days enoxaparin)
PRIMARY EFFICACY ENDPOINT*
(assessed for noninferiority)
- Total VTE/all-cause death
SAFETY ENDPOINTS
- Major bleeding
- Major + CRNM bleeding
- All bleeding
