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

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ClinicalTrials.gov Identifier: NCT01203098

Recruitment Status : Completed

First Posted : September 16, 2010

Results First Posted : February 9, 2015

Last Update Posted : February 25, 2019

Sponsor:

Information provided by (Responsible Party):

Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Study Description

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

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban Edoxaban tosylate Enoxaparin sodium

U.S. FDA Resources

Arms and Interventions

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

Primary Outcome Measures :

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 :

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

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203098

Locations

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Japan

Osaka, Japan

Tokyo, Japan
Taiwan

Kaohsiung, Taiwan

Sponsors and Collaborators

Daiichi Sankyo Co., Ltd.

Investigators

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Principal Investigator:	Takeshi Fuji	Osaka Koseinenkin Hospital

More Information

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.

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Responsible Party:	Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01203098
Other Study ID Numbers:	DU176b-B-J209
First Posted:	September 16, 2010 Key Record Dates
Results First Posted:	February 9, 2015
Last Update Posted:	February 25, 2019
Last Verified:	February 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR)
Time Frame:	Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria:	Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL:	https://vivli.org/ourmember/daiichi-sankyo/

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


prevention venous thromboembolism edoxaban anticoagulants

Additional relevant MeSH terms:

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

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