Conditions: Venous Thrombosis Pulmonary Embolism
Keywords: Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6758
Healthy volunteers: no

Brief summary:
The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Detailed description:

Arms:
arm 1: While hospitalized, Apixaban plus Placebo

Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC)

After hospital discharge, Apixaban

Apixaban (Tablets, Oral, 2.5 mg) arm 2: While hospitalized, Enoxaparin plus Placebo

Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)

After hospital discharge: Placebo

Placebo (Tablets, Oral)

Interventions: intervention 1: Apixaban intervention 2: Enoxaparin
Intervention descriptions: intervention 1: Apixaban: Twice daily, 30 days

Placebo: Once daily, 6-14 days intervention 2: Enoxaparin: Once daily, 6-14 days

Placebo: Twice daily, 30 days

Protocol document: