A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty

Study Overview
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Brief Summary
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The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.

Official Title
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A Phase 2b, Randomized, Multi-Dose Efficacy,Safety Study of the Oral Factor Xa Inhibitor DU-176b Versus Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty (STARS J-2)

Conditions
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Venous Thromboembolism, Thromboembolism, Thrombosis, Embolism and Thrombosis, Deep Vein Thrombosis, Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Drug: DU-176b 15mg
* Drug: DU-176b 30mg
* Drug: Enoxaparin sodium 20 mg (=2000IU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral total hip arthroplasty Patients who are 20-84 years olds 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
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Minimum Age: 20 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DU-176b 30mg once daily<br>DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery | Drug: DU-176b 30mg<br>* DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.<br>* Other names: edoxaban;|
| Active Comparator: Enoxaparin sodium twice daily<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 20 mg (=2000IU)<br>* Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.<br>|
| Experimental: DU-176b 15mg once daily<br>DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery | Drug: DU-176b 15mg<br>* DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.<br>* Other names: edoxaban;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage 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 DVT confirmed by bilateral venography at the end of study treatment Definite diagnosis of symptomatic 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 VTE | 2 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, venous thromboembolism, edoxaban, anticoagulants