Conditions: Deep Vein Thrombosis Pulmonary Embolism
Keywords: Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3221
Healthy volunteers: no

Brief summary:
The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.

Detailed description:

Arms:
arm 1: Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery. arm 2: Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.

Interventions: intervention 1: Enoxaparin intervention 2: Apixaban intervention 3: Enoxaparin-matching placebo intervention 4: Apixaban-matching placebo
Intervention descriptions: intervention 1: 40 mg, administered once daily by subcutaneous injection, for 12 days intervention 2: 2.5 mg, administered twice daily as tablets, for 12 days intervention 3: Administered once daily by subcutaneous injection intervention 4: Oral tablet administered twice daily

Protocol document: