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

This study has been completed.
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. ) Identifier:
First received: August 12, 2010
Last updated: February 3, 2015
Last verified: February 2015
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.

Condition Intervention Phase
Venous Thromboembolism
Drug: edoxaban
Drug: enoxaparin sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)

Resource links provided by NLM:

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Incidence of Subjects With Venous Thromboembolism Events. [ Time Frame: 2 weeks ]

    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)

Secondary Outcome Measures:
  • Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding. [ Time Frame: 2 weeks ]

Enrollment: 716
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DU-176b
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery.
Drug: edoxaban
Active Comparator: enoxaparin sodium
enoxaparin sodium 20mg (=2000IU) 0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.
Drug: enoxaparin sodium


Ages Eligible for Study:   20 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01181102

Osaka, Japan
Tokyo, Japan
Kaohsiung, Taiwan
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Principal Investigator: Takeshi Fuji Osaka Koseinenkin Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Daiichi Sankyo Co., Ltd. Identifier: NCT01181102     History of Changes
Other Study ID Numbers: DU176b-B-J302
Study First Received: August 12, 2010
Results First Received: January 15, 2015
Last Updated: February 3, 2015

Keywords provided by Daiichi Sankyo Inc.:
embolism and thrombosis
venus thromboembolism
deep vein thrombosis
factor Xa
total knee arthroplasty
Enoxaparin sodium

Additional relevant MeSH terms:
Embolism and Thrombosis
Venous Thromboembolism
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents processed this record on May 23, 2017