A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
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| ClinicalTrials.gov Identifier: NCT01181102 |
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Recruitment Status :
Completed
First Posted : August 13, 2010
Results First Posted : February 19, 2015
Last Update Posted : March 5, 2019
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Sponsor:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Venous Thromboembolism | Drug: edoxaban Drug: enoxaparin sodium | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 716 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (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) |
| Study Start Date : | March 2009 |
| Actual Primary Completion Date : | September 2009 |
| Actual Study Completion Date : | February 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Knee Replacement
| Arm | Intervention/treatment |
|---|---|
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Experimental: DU-176b
DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery.
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Drug: edoxaban |
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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.
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Drug: enoxaparin sodium |
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 ]
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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 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.
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): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daiichi Sankyo Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01181102 |
| Other Study ID Numbers: |
DU176b-B-J302 |
| First Posted: | August 13, 2010 Key Record Dates |
| Results First Posted: | February 19, 2015 |
| Last Update Posted: | March 5, 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. ):
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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:
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Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Enoxaparin Enoxaparin sodium Edoxaban Anticoagulants |
Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |