Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

Summary

To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group: * Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality * Incidence of DVT (total, proximal, distal) * Incidence of nonfatal PE * Incidence of symptomatic VTE (DVT, PE) * VTE caused mortality * Non-VTE caused mortality * Incidence of all hemorrhagic complications * Incidence of major and clinically relevant non-major bleeding * Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results

Timeline

Start

2013-08

Primary completion

2015-09

Completion

2015-09

Drugs

Indications

No indication recorded.