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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01181102
First received: August 12, 2010
Last updated: February 3, 2015
Last verified: February 2015
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181102

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

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov 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
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Daiichi Sankyo Inc.:
anticoagulant
venus thromboembolism
thrombosis
thromboembolism
embolism and thrombosis
deep vein thrombosis
DU-176b
Edoxaban
factor Xa
total knee arthroplasty
Enoxaparin sodium

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Enoxaparin
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015