Conditions: Deep Vein Thrombosis Pulmonary Embolism
Keywords: Prevention of deep vein thrombosis and pulmonary embolism after total hip replacement surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5407
Healthy volunteers: no

Brief summary:
The purpose of this study is to learn whether apixaban can prevent the blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism) that sometimes occur after hip replacement surgery and to learn how apixaban compares with enoxaparin in preventing these clots. The safety of apixaban will also be studied

Detailed description:

Arms:
arm 1: Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD) arm 2: Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID

Interventions: intervention 1: Enoxaparin intervention 2: Apixaban intervention 3: Enoxaparin-matching placebo intervention 4: Apixaban-matching placebo
Intervention descriptions: intervention 1: Subcutaneous, 40 mg, once daily, 5 weeks intervention 2: Oral tablets, 2.5 mg, twice daily, 5weeks intervention 3: Administered as injection intervention 4: Administered as oral tablets

Protocol document: