Venous ThromboembolismNCT02952599
Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Korea and Taiwan (ETNA-VTE-KOR-TWN)
An observational study of Venous Thromboembolism, run by Daiichi Sankyo at 19 sites in 2 countries.
Trial summary
According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Edoxaban
- How many people
- 352 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 27 Mar 2017to 29 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with established acute initial or recurrent VTE treated with edoxaban according to package information. To ensure that the physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban. Patients must have provided written informed consent for participation in the study (ICF) and should not participate simultaneously in any interventional study.
Who may be able to join
- Established acute initial or recurrent VTE
- Patients prescribed treatment with edoxaban according to package information before participation in the trial
- Written informed consent for participation in the study (ICF)
- Not simultaneously participating in any interventional study
Who cannot join
- None
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Taiwan10 sites
Changhua Christian Hospital
Chang-hua, 500
Chang Gung Memorial Hospital, KaoHsiung
Kaohsiung City, Niaosong District, 83301
KaoHsiung Veterans General Hospital
Kaohsiung City, Zuoying District, 81362
Far Eastern Memorial Hospital
New Taipei City, Banciao District, 22060
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
Taipei Veterans General Hospital
Taipei, Beitou District, 11217
Cheng Hsin General Hospital
Taipei, Pai-Tou, 11220
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Shih Lin District, 11101
National Taiwan University Hospital
Taipei, Zhongzheng District, 10002
South Korea9 sites
Inje University Haeundae Paik Hospital
Busan, Haeundae-gu, 48108
Pusan National University Hospital
Busan, Seo-gu, 49241
Keimyung University Dongsan Medical Center
Daegu
SoonChunHyang University Hospital Gumi
Gyeongsang, Gumi, 39371
Dong-A University Hospital
Seogu, Kwang-Jo Cho
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, 03722
SoonChunHyang University Hospital Seoul
Seoul, Yongsan-gu, 04401
Yonsei University, Wonju Severance Christian Hospital
Wŏnju, 26426
About this study
Official title: Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism (VTE) in Korea and Taiwan
According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months.
Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in an unselected patient population in routine clinical practice.
Read the detailed description
Edoxaban is an orally administered anticoagulant that inhibits coagulation factor Xa. It has been approved by the Ministry of Food and Drug Safety (MFDS) in Korea (date: 25th, August 2015) for the: Reduction in the risk of stroke and systemic embolism in patients with non valvular atrial fibrillation (NVAF) Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) Reduction in the risk of recurrent DVT and PE, and by Taiwan Food and Drug Administration (TFDA) in Taiwan (date: 24th, February, 2016) for the Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.
According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months.
This non-interventional study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in approximately 350 patients in an unselected patient population in routine clinical practice.
- Conditions
- Venous Thromboembolism
- Being tested
- Edoxaban
- Keywords
- Non-interventional Study, Real World Evidence, Patients with Acute VTE treated with Edoxaban, Efficacy/Safety
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Also called Lixiana
Prescribed according to approved label
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Edoxaban | Patients with established acute initial or recurrent VTE treated with edoxaban according to Summary of Product Characteristics (SmPC). Physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban. Receives: Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of overall symptomatic VTE recurrence
Rate of overall symptomatic VTE recurrence within 12 months
Measured: Baseline to 12 months
Rate of participants experiencing Real World Safety Data Events
Categories: VTE-related bleeding events, Drug-related adverse events, Cardiovascular Mortality, and All-cause Mortality
Measured: 12 months
Secondary outcomes (3)
Rate of participants taking edoxaban with symptomatic VTE recurrence
Rate of participants taking edoxaban with symptomatic VTE recurrence in 12 months
Measured: 12 months
Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence
Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence in 12 months
Measured: 12 months
Rate of participants with patient relevant outcomes
Patient relevant outcomes include bleeding events, strokes (ischaemic and haemorrhagic), systemic embolic events (SEE), and hospitalisations related to cardiovascular (CV) condition (including VTE related hospitalisation).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start27 Mar 2017
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952599
- Sponsor's protocol ID
- DU176b-D-A4010
- Status last verified
- Dec 2019
- First submitted
- 31 Oct 2016
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- 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
Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.
PubMed 23991658
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism (VTE) in Korea and Taiwan
- ClinicalTrials.gov ID
- NCT02952599
- Acronym / sponsor ID
- DU176b-D-A4010
- Conditions
- Venous Thromboembolism
- Keywords
- Non-interventional Study, Real World Evidence, Patients with Acute VTE treated with Edoxaban, Efficacy/Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months.
Therefore, this study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in an unselected patient population in routine clinical practice.
Detailed description
Edoxaban is an orally administered anticoagulant that inhibits coagulation factor Xa. It has been approved by the Ministry of Food and Drug Safety (MFDS) in Korea (date: 25th, August 2015) for the: Reduction in the risk of stroke and systemic embolism in patients with non valvular atrial fibrillation (NVAF) Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) Reduction in the risk of recurrent DVT and PE, and by Taiwan Food and Drug Administration (TFDA) in Taiwan (date: 24th, February, 2016) for the Prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.
According to current guidelines, duration of anticoagulant treatment after a venous thromboembolic event varies from 3 months to indefinite treatment depending on the estimated risks of venous thromboembolism (VTE) recurrence and bleeding. Current data for edoxaban are limited to a maximum treatment duration of 12 months.
This non-interventional study aims to gather further insight into efficacy (i.e. symptomatic recurrent VTE) and safety (i.e. bleeding events, liver adverse events, all-cause mortality and other drug related adverse events) of extended treatment with edoxaban up to 12 months in approximately 350 patients in an unselected patient population in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Edoxaban | – | Drug: EdoxabanPatients with established acute initial or recurrent VTE treated with edoxaban according to Summary of Product Characteristics (SmPC). Physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with established acute initial or recurrent VTE treated with edoxaban according to package information. To ensure that the physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban. Patients must have provided written informed consent for participation in the study (ICF) and should not participate simultaneously in any interventional study.
Key inclusion criteria (4 listed)
- Established acute initial or recurrent VTE
- Patients prescribed treatment with edoxaban according to package information before participation in the trial
- Written informed consent for participation in the study (ICF)
- Not simultaneously participating in any interventional study
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| EdoxabanAlso: LixianaPrescribed according to approved label | Drug | Patients treated with Edoxaban |
Primary outcome
Rate of overall symptomatic VTE recurrence
Time frame: Baseline to 12 months
Rate of overall symptomatic VTE recurrence within 12 months
Rate of participants experiencing Real World Safety Data Events
Time frame: 12 months
Categories: VTE-related bleeding events, Drug-related adverse events, Cardiovascular Mortality, and All-cause Mortality
3 secondary outcomes
Rate of participants taking edoxaban with symptomatic VTE recurrence
Time frame: 12 months
Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence
Time frame: 12 months
Rate of participants with patient relevant outcomes
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Background: PubMed 23991658Hokusai-VTE Investigators; Buller HR, Decousus H, Grosso MA, Mercuri M, Middeldorp S, Prins MH, Raskob GE, Schellong SM, Schwocho L, Segers A, Shi M, Verhamme P, Wells P. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2013 Oct 10;369(15):1406-15. doi: 10.1056/NEJMoa1306638. Epub 2013 Aug 31.
- 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/
Related trials for Venous Thromboembolism
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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.
Global Clinical Leader study director
Daiichi Sankyo
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Daiichi Sankyo at 19 sites in 2 countries.
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 4 inclusion and 1 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 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Taiwan, South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of overall symptomatic VTE recurrence (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. 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 NCT02952599, 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 23 Dec 2019.