A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS E-3 Trial)

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: edoxaban
* Drug: enoxaparin sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing unilateral total knee arthroplasty Exclusion Criteria: Subjects with risks of hemorrhage Subjects with thromboembolic risks Subjects who weigh less than 40 kg Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 84 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DU-176b<br>DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery. | Drug: edoxaban<br> <br> |
| Active Comparator: enoxaparin sodium<br>enoxaparin sodium 20mg (=2000IU) 0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery. | Drug: enoxaparin sodium<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Subjects With Venous Thromboembolism Events. | The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment. Lower extremity Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment Definite diagnosis of symptomatic Pulmonary Embolism (PE) Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of venous Thromboembolism (VTE) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anticoagulant, venus thromboembolism, thrombosis, thromboembolism, embolism and thrombosis, deep vein thrombosis, DU-176b, Edoxaban, factor Xa, total knee arthroplasty, Enoxaparin sodium