UMIN-CTR Clinical Trial

Public title

Multicenter study associated with KYU-shu to evaluate the efficacy and safety of edoxaban in patients with non-valvulaR Atrial fiBriLlation undergoing cathEter ablation.

Acronym

KYU-RABLE STUDY

Scientific Title

Multicenter study associated with KYU-shu to evaluate the efficacy and safety of edoxaban in patients with non-valvulaR Atrial fiBriLlation undergoing cathEter ablation.

Scientific Title:Acronym

KYU-RABLE STUDY

Region

Japan

Condition

patients with non-valvular atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We will consider and evaluate multicenter collaborative clinical research for safety and effectiveness of oral anti-Xa inhibitorin edoxaban by catheter ablation perioperative period for patients with non-valvular atrial fibrillation.
Secondarily, We will consider variation of thrombotic / thrombolytic biomarkers by catheter ablation perioperative period.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Combination of thromboembolic events (Stroke / systemic embolism) and major bleeding for 4 weeks from the date of catheter ablation.

Key secondary outcomes

1) The following expression rate events for 4 weeks from the date of by catheter ablation.
-All death
-Stroke / systemic embolism
-Major bleeding
-Clinically relevant non major bleeding
-Minor bleeding
-Cardiovascular events
-All adverse events
2) The variation of thrombotic / thrombolytic biomarkers by catheter ablation perioperative period.

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

Method for administration of Edoxaban
Until the day before catheter ablation : Oral administration for 4 weeks or more is performed every morning.
The day of catheter ablation : After the ablation, hemostasis is confirmed at the puncture site, and oral administration is performed.
The next day of catheter ablation : Oral administration 12 hour after the administration on the day of the ablation.
After two days later : Oral administration for 4 weeks or more is performed every morning.

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) Patient definitively diagnosed as non-valvular atrial fibrillation.
2) Patients scheduled to undergo catheter ablation for non-valvular atrial fibrillation.
3) Patients who have given informed consent in writing from oneself.( 20 years of age or older)

Key exclusion criteria

(1) Patients falling under the administration contraindication for non-valvular atrial fibrillation of Edoxaban formulation.
(2) Patients who are creatinine clearance <30 mL/min.
(3) Patients contraindicated to undergo catheter ablation.
(4) Patients who developed thromboembolism or myocardial infarction within 2 months before registration.
(5) Patients who can't interrupt administration of antiplatelet drugs one week before catheter ablation is performed.
(6) Patients of CHADS2 score is 6 points.
Such as 18 items.

Target sample size

550

Name of lead principal investigator

1st name
Middle name
Last name	Naohiko Takahashi

Organization

Oita University Medical School

Division name

Department of Cardiology Clinical laboratory diagnostic lecture course Professor

Zip code

Address

1-1 Hasamamachiidaigaoka, Yufu-city, Oita-prefecture, 879-5593,Japan

TEL

097-549-4411

Email

maejima.tetsuya.j3@rdn.daiichisankyo.co.jp

Name of contact person

1st name
Middle name
Last name	Tetsuya Maejima

Organization

DAIICHI SANKYO RD NOVARE CO., LTD.

Division name

Clinical Development Group3 Clinical Development Department

Zip code

Address

1-2-58,Hiromachi, Shinagawa-ku Tokyo 140-8710,Japan

TEL

03-5436-8543

Homepage URL

Email

maejima.tetsuya.j3@rdn.daiichisankyo.co.jp

Institute

DAIICHI SANKYO CO., LTD.

Institute

Department

Personal name

Organization

DAIICHI SANKYO CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

10

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

541

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

Completed

Date of protocol fixation

2017

Year

09

Month

26

Day

Date of IRB

2017

Year

11

Month

12

Day

Anticipated trial start date

2017

Year

12

Month

01

Day

Last follow-up date

2018

Year

11

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

10

Month

24

Day

Last modified on

2019

Year

04

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033933