Multicenter, Randomized, Double-blind, Double-dummy, Noninferiority, Phase 3 Study
Patient Characteristics
- Age ≥ 18 years
- Scheduled for THR surgery
Apixaban 2.5 mg BID
(n = 2708)
(n = 2708)
Enoxaparin 40 mg QD
(n = 2699)
(n = 2699)
Continued prophylaxis
at the discretion of
the investigator
at the discretion of
the investigator
R
N = 5407
Treatment Period
35 ± 3 Days
35 ± 3 Days
Follow-up Period
65 ± 5 days and 95 ± 5 days
65 ± 5 days and 95 ± 5 days
Mandatory Bilateral
Venography
Venography
Randomized, Double-blind, Double-dummy Design
- Randomized, double-blind, double-dummy design
- Apixaban initiated 12 to 24 hours after wound closure
- Enoxaparin initiated 12 ± 3 hours preoperatively and resumed 12 to 24 hours after wound closure according to the investigator’s standard
of care
- Preoperative injection mean of 13.6 hours before surgery
- Postoperative dose of study medication mean of ~19 hours after wound closure
