At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
In Brief
A Phase 3 clinical trial evaluating Enoxaparin, warfarin, and 4 other interventions for Venous Thrombosis. Completed, enrolled 5,614 participants across 381 sites in 31 countries.
Detailed 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)
Study Details
Timeline
Interventions
solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.
tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.
tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months