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

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)

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.

Study Overview

• Status: Completed
• Conditions: Embolism and Thrombosis; Thrombosis; Deep Vein Thrombosis; Thromboembolism; Venous Thromboembolism; Arthroplasty, Replacement, Hip
• Intervention / Treatment: Drug: DU-176b 30mg; Drug: Enoxaparin sodium 20 mg (=2000IU); Drug: DU-176b 15mg

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
  • Tokyo, Japan
• Taiwan
  • Kaohsiung, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: edoxaban

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Co., Ltd.
• Investigators: Principal Investigator: Takeshi Fuji, Osaka Koseinenkin Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: prevention; anticoagulants; venous thromboembolism; edoxaban
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Embolism and Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: DU176b-B-J209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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/
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR