UMIN-CTR Clinical Trial

Public title

Real world ablation therapy with anticoagulants in management of atrial fibrillation

Acronym

RYOUMA Registry

Scientific Title

Real world ablation therapy with anticoagulants in management of atrial fibrillation

Scientific Title:Acronym

RYOUMA Registry

Region

Japan

Condition

Non-Valvular Atrial Fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study will be conducted to investigate real world anticoagulant therapy and its outcomes in patients receiving catheter ablation for NVAF and to separately assess the usefulness of oral anticoagulants in populations of patients receiving RF, CB, or HB ablation.
In addition, global assessment will be performed to find the most suitable target patient populations and the optimal regimen for edoxaban.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The overall incidence of adverse events during the follow-up period.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria at the time of giving informed consent are eligible as subjects of
this study.
(1) Patients with a diagnosis of NVAF.
(2) Patients scheduled to undergo catheter ablation

Key exclusion criteria

Patients who meet any of the following criteria will be excluded from this study.
(1) It is impossible to obtain written informed consent from the patient or a legal representative.
(2) Current or scheduled participation in a clinical trial involving pharmacotherapy
(3) Not the first catheter ablation
(3) Any other reason that disqualifies the patient from participating in this study in the investigator's opinion

Target sample size

3000

Name of lead principal investigator

1st name	Akihiko
Middle name
Last name	Nogami

Organization

Faculty of Medicune, University of Tsukuba

Division name

Cardiovascular Division (Arrhythmia)

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575 Japan

TEL

029-853-3142

Email

akihiko-ind@umin.ac.jp

Name of contact person

1st name	Kazushuge
Middle name
Last name	Oishi

Organization

Mediscience Planning Inc.

Division name

Medical Information Div.

Zip code

103-0007

Address

1-2-1 Nihonbashihamacho, Chuo-ku, Tokyo, 103-0007 Japan

TEL

03-5820-7026

Homepage URL

Email

info-ryouma@mpi-cro.jp

Institute

University of Tsukuba

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

University of Tsukuba Hospital Clinical Research Ethics Review Committee

Address

2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576

Tel

029-853-3914

Email

t-credo.adm@un.tsukuba.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

筑波大学附属病院（茨城県）、他68施設

Date of disclosure of the study information

2017

Year

02

Month

10

Day

URL releasing protocol

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwiatI6pq4z7A

Publication of results

Published

URL related to results and publications

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwiatI6pq4z7A

Number of participants that the trial has enrolled

3170

Results

Of the 3,072 patients who underwent CA, 82.3% received minimally interrupted DOACs and 10.2% received uninterrupted DOACs. Extremely low thromboembolic events occurred with or without interruption. The incidence of major bleeding events was 3.9%. At 1 year after CA, DOAC was continued in 55.9% and warfarin in 56.4%. The incidence of thromboembolic and major bleeding events for 1 year was 0.3% and 1.2%. Age >=73 years, dementia, and AF recurrence were independently associated with major bleeding events.

Results date posted

2022

Year

11

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2022

Year

08

Month

20

Day

Baseline Characteristics

The median age was 68.0 years and 71.1% were men. More than half of the patients (64.2%) had paroxysmal AF (PAF) and 36.6% had a CHADS2 score of >=2. Most patients (92.6%) had received DOACs. The warfarin group was significantly older and had a significantly lower creatinine clearance (CrCl), higher CHADS2, CHA2DS2-VASc, and HAS-BLED scores than the DOAC group.
In patients with DOACs, 40.2% received twice-daily (BID) DOACs and 59.8% received once-daily (QD) DOACs. Most patients (82.3%) had received minimally interrupted DOAC therapy before the CA. Regarding the interval between the last DOAC administration and the first puncture for the CA (D-A interval), of the 1,143 patients receiving BID-DOACs, the D-A interval was <12 h in 123 (10.8%), 12 to <24 h in 793 (69.4%), and >=24 h in 170 (14.9%). Of the 1,701 patients who received QD-DOACs, the D-A interval was <24 h in 325 (19.1%), 24 to <36 h in 1,185 (69.7%), and >=36 h in 65 (3.8%). Most patients had one dose held for both BID and QD-DOACs. The intraprocedural heparin requirement was significantly higher in the DOAC subgroups who had a D-A interval of 12 to <24 h (median 11,500 IU [IQR, 9,000-14,900]) and >=24 h (12,000 IU [IQR, 10,000-15,000]) than in the DOAC subgroup who had D-A intervals <12 h (8,000 IU [IQR, 6,000-11,141]) (all P<0.0001). The median intraprocedural heparin requirement in the warfarin group was 8,700 IU (IQR, 7,000-11,000).

Participant flow

A total of 3,170 patients were enrolled during the registration period, of whom 33 were excluded. Fifty-nine patients were further excluded because they did not undergo CA, and 6 were excluded due to incomplete data. In total, 3,072 patients underwent CA and were included in the analyses.

Adverse events

AEs were occurred in 29.5% of the warfarin group and in 29.4% of the DOAC group in the periprocedural period. AEs were occurred 36.5% in the warfarin group and 23.7% in the DOAC group in the remote period.

Outcome measures

Primary endpoint: Incidence of adverse events during the follow-up period.
Secondary endpoints: Incidence of the following events during the follow-up period: All-cause death, Cardiovascular death, stroke /systemic embolic events, Heart disease, Intracranial hemorrhage, Gastrointestinal hemorrhage, Major bleeding events, Clinically relevant non-major bleeding events, Major bleeding events + clinically relevant non-major bleeding events, Cardiovascular adverse events

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

01

Month

16

Day

Date of IRB

2017

Year

01

Month

16

Day

Anticipated trial start date

2017

Year

02

Month

13

Day

Last follow-up date

2019

Year

06

Month

30

Day

Date of closure to data entry

2019

Year

08

Month

31

Day

Date trial data considered complete

2020

Year

04

Month

27

Day

Date analysis concluded

Other related information

Major observation items to be examined for the relationship with primary and secondary outcomes are: patient background, CHASD2 score, CH2DS2-Vasc score, blood test, type of catheter ablation, use of drug (antiarrhythmic, anticoagulant, antiplatelet)

Registered date

2017

Year

02

Month

10

Day

Last modified on

2022

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029983