PreventionPhase 3NCT01181167

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

A Phase 3 study testing edoxaban and enoxaparin sodium in people with Prevention and Venous Thromboembolism, run by Daiichi Sankyo Co., Ltd. at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 hip arthroplasty. Read more about this study

Who is it for?: Ages 20 to 84 years
Conditions the study is for: Prevention, Venous Thromboembolism
What is being tested?: edoxaban and enoxaparin sodium
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 610 participants
Where: 2 sitesJapan
Study dates: May 2009to Mar 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 84 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients undergoing unilateral total hip arthroplasty

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Study site
Osaka
Study site
Tokyo

Other trials in Japan

About this study

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 Hip Arthroplasty (STARS J-5 Trial)

Conditions: Prevention, Venous Thromboembolism
Being tested: edoxaban, enoxaparin sodium
Keywords: Anticoagulants, Venous thromboembolism, Thromboembolism, Thrombosis, enoxaparin sodium, Embolism, Deep vein thrombosis, DU-176b, edoxaban, factor Xa, total hip arthroplasty
Medical subject headings: Venous Thromboembolism, Thromboembolism, Thrombosis, Embolism, Venous Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

edoxabanDrug
enoxaparin sodiumDrug

Study groups in NCT01181167
Study group	Role	What they receive
DU-176b	Experimental	DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery. Receives: Drug: edoxaban
enoxaparin sodium	Active comparator	enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery. Receives: Drug: enoxaparin sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence 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
Measured: 2 weeks

Secondary outcomes (1)

Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Mar 2010

First posted13 Aug 2010 (estimated)
Study startMay 2009
Primary completionJan 2010
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PreventionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 610 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01181167
Sponsor's protocol ID: DU176b-B-J304
Status last verified: Feb 2015
First submitted: 12 Aug 2010
Last updated: 5 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: 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/

Publications

Kawai Y, Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S. Edoxaban versus enoxaparin for the prevention of venous thromboembolism after total knee or hip arthroplasty: pooled analysis of coagulation biomarkers and primary efficacy and safety endpoints from two phase 3 trials. Thromb J. 2016 Dec 1;14:48. doi: 10.1186/s12959-016-0121-1. eCollection 2016.
PubMed 27980462

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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 Hip Arthroplasty (STARS J-5 Trial)
ClinicalTrials.gov ID: NCT01181167
Acronym / sponsor ID: DU176b-B-J304
Conditions: Prevention, Venous Thromboembolism
Keywords: Anticoagulants, Venous thromboembolism, Thromboembolism, Thrombosis, enoxaparin sodium, Embolism, Deep vein thrombosis, DU-176b
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 610 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Jan 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 13 Aug 2010 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DU-176b	Experimental	Drug: edoxabanDU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery.
enoxaparin sodium	Active comparator	Drug: enoxaparin sodiumenoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.

Who may qualify

Ages: 20 to 84 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients undergoing unilateral total hip arthroplasty

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
edoxaban	Drug	DU-176b
enoxaparin sodium	Drug	enoxaparin sodium

Primary outcome

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 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

1 secondary outcome

Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding
Time frame: 2 weeks

Results and safety

Results posted to the registry on 26 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DU-176b	307	284
Enoxaparin Sodium	303	271

Primary outcome: Incidence of Subjects With Venous Thromboembolism Events

Time frame: 2 weeks. Number (95% Confidence Interval). Unit: percentage of subjects with vte events

Measure	DU-176b n = 255	Enoxaparin Sodium n = 248
Value	2.4 (1.1 to 5.0)	6.9 (4.3 to 10.7)

DU-176b vs Enoxaparin Sodium: Cox Proportional Hazard: -4.5, p <0.001, ANCOVA

Population analysed: The FAS was defined as all subjects enrolled in the study, but excluded those who had significant GCP violations, who had not received any doses of the study drug, or those who did not develop symptomatic DVT or PE, but in whom venography was not appropriately performed.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DU-176b	9 of 303 (3%)	197 of 303 (65%)	Not reported
Enoxaparin Sodium	9 of 301 (3%)	232 of 301 (77.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27980462Kawai Y, Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S. Edoxaban versus enoxaparin for the prevention of venous thromboembolism after total knee or hip arthroplasty: pooled analysis of coagulation biomarkers and primary efficacy and safety endpoints from two phase 3 trials. Thromb J. 2016 Dec 1;14:48. doi: 10.1186/s12959-016-0121-1. eCollection 2016.
Individual participant dataSharing planned: Yes. 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/

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Takeshi Fuji principal investigator

Osaka Koseinenkin Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing edoxaban and enoxaparin sodium in people with Prevention and Venous Thromboembolism, run by Daiichi Sankyo Co., Ltd. at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Subjects With Venous Thromboembolism Events (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01181167, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.