Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism in Korea and Taiwan (ETNA-VTE-KOR-TWN)

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02952599

Collaborator

(none)

352

Enrollment

Locations

31.1

Actual Duration (Months)

18.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism	Drug: Edoxaban

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.

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

Study Type:

Observational

Actual Enrollment :

352 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice in Patients With Venous Thromboembolism (VTE) in Korea and Taiwan

Actual Study Start Date :

Mar 27, 2017

Actual Primary Completion Date :

Oct 29, 2019

Actual Study Completion Date :

Oct 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Edoxaban Prescribed according to approved label Other Names: Lixiana

Arm

Intervention/Treatment

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.

Drug: Edoxaban

Prescribed according to approved label

Other Names:

Lixiana

Outcome Measures

Primary Outcome Measures

Rate of overall symptomatic VTE recurrence [Baseline to 12 months]
Rate of overall symptomatic VTE recurrence within 12 months
Rate of participants experiencing Real World Safety Data Events [12 months]
Categories: VTE-related bleeding events, Drug-related adverse events, Cardiovascular Mortality, and All-cause Mortality

Secondary Outcome Measures

Rate of participants taking edoxaban with symptomatic VTE recurrence [12 months]
Rate of participants taking edoxaban with symptomatic VTE recurrence in 12 months
Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence [12 months]
Rate of participants who permanently discontinued edoxaban with symptomatic VTE recurrence in 12 months
Rate of participants with patient relevant outcomes [12 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SoonChunHyang University Hospital Gumi	Gyeongsang	Gumi	Korea, Republic of	39371
2	Inje University Haeundae Paik Hospital	Busan	Haeundae-gu	Korea, Republic of	48108
3	Seoul National University Hospital	Seoul	Jongno-gu	Korea, Republic of	03080
4	Dong-A University Hospital	Seogu	Kwang-Jo Cho	Korea, Republic of
5	Pusan National University Hospital	Busan	Seo-gu	Korea, Republic of	49241
6	Severance Hospital, Yonsei University Health System	Seoul	Seodaemun-gu	Korea, Republic of	03722
7	SoonChunHyang University Hospital Seoul	Seoul	Yongsan-gu	Korea, Republic of	04401
8	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
9	Yonsei University, Wonju Severance Christian Hospital	Wŏnju		Korea, Republic of	26426
10	Far Eastern Memorial Hospital	New Taipei City	Banciao District	Taiwan	22060
11	Taipei Veterans General Hospital	Taipei	Beitou District	Taiwan	11217
12	Chang Gung Memorial Hospital, KaoHsiung	Kaohsiung	Niaosong District	Taiwan	83301
13	Cheng Hsin General Hospital	Taipei	Pai-Tou	Taiwan	11220
14	Shin Kong Wu Ho-Su Memorial Hospital	Taipei	Shih Lin District	Taiwan	11101
15	National Taiwan University Hospital	Taipei	Zhongzheng District	Taiwan	10002
16	KaoHsiung Veterans General Hospital	Kaohsiung	Zuoying District	Taiwan	81362
17	Changhua Christian Hospital	Chang-hua		Taiwan	500
18	China Medical University Hospital	Taichung		Taiwan	40447
19	Taichung Veterans General Hospital	Taichung		Taiwan	40705