Conditions: Venous Thrombosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5614
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Detailed description:

Arms:
arm 1: apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months. arm 2: Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.

Interventions: intervention 1: Enoxaparin intervention 2: warfarin intervention 3: Placebo for apixaban intervention 4: Placebo for enoxaparin intervention 5: Placebo for warfarin intervention 6: apixaban
Intervention descriptions: intervention 1: solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2. intervention 2: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months intervention 3: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months intervention 4: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2. intervention 5: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months intervention 6: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months

Protocol document: