UMIN-CTR Clinical Trial

Public title

A study on efficacy and safety of Edoxaban on high-risk gastrointestinal endoscopic procedures

Acronym

Edoxaban study

Scientific Title

A study on efficacy and safety of Edoxaban on high-risk gastrointestinal endoscopic procedures

Scientific Title:Acronym

Edoxaban study

Region

Japan

Condition

All diseases that require high-risk gastrointestinal endoscopic procedures such as endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection or endoscopic mucosal ablation

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To reveal the rate of bleeding or thromboembolism during the periendoscopic period when using edoxaban (DOAC: direct oral anticoagulant) instead of warfarin for antithrombotic therapy during the perioperative period of high-risk gastrointestinal endoscopic procedures

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Post-procedural bleeding rate (soon after registration to 2 months after endoscopic procedures, >= CTCAE v4.0 Grade 3)

Key secondary outcomes

1) Thromboembolism rate (soon after registration to 2 months after endoscopic procedures)
2) All complication rate (soon after registration to 2 months after endoscopic procedures)
3) Post-procedural bleeding rate (soon after registration to 2 months after endoscopic procedures, >= CTCAE v4.0 Grade 1)
4) Length of hospital stay

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Replace warfarin to edoxaban before endoscopic procedures

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Japanese patients taking warfarin or edoxaban to prevent thromboembolism caused by non-valvular atrial fibrillation or recurrence of deep vein thrombus
2) 20 years old or older
3) Performance status (ECOG) of 0 to 2
4) Hb: >=9 g/dl
5) Plt: >=100000 /mm3
6) AST, ALT: <=150 U/l
7) eGFR: >=30 ml/min
8) Written informed consent

Key exclusion criteria

1) Patients with clinical bleeding tendency
2) Patient during the other antithrombotic agent except warfarin or edoxaban
3) Allergy to DOAC
4) Patient during azole antifungal drugs
5) Pregnant or lactation woman
6) Patient with mitral stenosis or replacement of the artificial valve
7) Patient with a history of cardioembolic ischemic stroke
8) Patient with a history of ischemic stroke or TIA
9) Patient with anti-phospholipid antibody syndrome
10) Patient with a history of deep vein thrombosis or pulmonary embolism
11) Patients who are disqualified for the study by physicians
12) Patient with contraindication for edoxaban

Target sample size

40

Name of lead principal investigator

1st name	Shuji
Middle name
Last name	Terai

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Gastroenterology and Hepatology

Zip code

951-8510

Address

1-757 Asahimachidori, Chuo-ku, Niigata city

TEL

025-227-2207

Email

terais@med.niigata-u.ac.jp

Name of contact person

1st name	Junji
Middle name
Last name	Yokoyama

Organization

Niigata University Medical and Dental Hospital

Division name

Division of Endoscopy

Zip code

951-8520

Address

1-754 Asahimachidori, Chuo-ku, Niigata city

TEL

025-223-6161

Homepage URL

Email

yokoyaj@med.niigata-u.ac.jp

Institute

Niigata University Graduate School of Medical and Dental Sciences

Institute

Department

Personal name

Organization

Niigata University Graduate School of Medical and Dental Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Niigata University ethic screening committee

Address

1-757 Asahimachidori, Chuo-ku, Niigata city

Tel

0252272625

Email

https://niigata.bvits.com/rinri/

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

新潟大学医歯学総合病院（新潟県）

Date of disclosure of the study information

2018

Year

03

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

12

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2017

Year

10

Month

19

Day

Date of IRB

2018

Year

01

Month

22

Day

Anticipated trial start date

2018

Year

04

Month

01

Day

Last follow-up date

2020

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

02

Month

28

Day

Last modified on

2020

Year

03

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035983