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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Venous Thromboembolism; Thromboembolism; Thrombosis; Embolism and Thrombosis; Deep Vein Thrombosis; Arthroplasty, Replacement, Hip	Drug: DU-176b 15mg; Drug: DU-176b 30mg; Drug: Enoxaparin sodium 20 mg (=2000IU)	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	264 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	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)
Study Start Date :	July 2008
Actual Primary Completion Date :	December 2008
Actual Study Completion Date :	June 2009

Arms and Interventions

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

Outcome Measures

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Primary Outcome Measures :

1. Percentage 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 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

Secondary Outcome Measures :

1. Incidence of Major Bleeding or Clinically Relevant Non-major Bleedings. [ Time Frame: 2 weeks ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

1. Patients undergoing unilateral total hip arthroplasty
2. Patients who are 20-84 years olds

Exclusion Criteria:

1. Subjects with risks of hemorrhage
2. Subjects with thromboembolic risks
3. Subjects who weigh less than 40 kg
4. Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Contacts and Locations

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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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fuji T, Wang CJ, Fujita S, Kawai Y, Kimura T, Tachibana S. Safety and efficacy of edoxaban, an oral factor xa inhibitor, for thromboprophylaxis after total hip arthroplasty in Japan and Taiwan. J Arthroplasty. 2014 Dec;29(12):2439-46. doi: 10.1016/j.arth.2014.05.029. Epub 2014 Jun 9.

Responsible Party:	Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01203098 History of Changes
Other Study ID Numbers:	DU176b-B-J209
First Posted:	September 16, 2010
Results First Posted:	February 9, 2015
Last Update Posted:	February 9, 2015
Last Verified:	February 2015

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):

prevention; venous thromboembolism; edoxaban; anticoagulants

Additional relevant MeSH terms:

Thrombosis; Thromboembolism; Embolism; Venous Thromboembolism; Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Edoxaban; Enoxaparin	Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents