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

Total Knee Replacement Clinical Trial

Official title:
A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03088358
Study type Interventional
Source TeaRx LLC
Contact
Status Completed
Phase Phase 2
Start date August 2013
Completion date September 2015
View Details
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