UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014817
Receipt number R000017087
Scientific Title Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry - Rivaroxaban cohort
Date of disclosure of the study information 2014/08/11
Last modified on 2016/11/24 16:07:15

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Basic information

Public title

Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry - Rivaroxaban cohort

Acronym

JACRE-R

Scientific Title

Japanese Anti-Coagulation Regimen Exploration in AF Catheter Ablation Registry - Rivaroxaban cohort

Scientific Title:Acronym

JACRE-R

Region

Japan


Condition

Condition

Non-valvular atrial fibrillation patients scheduled to undergo the catheter ablation procedure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effectiveness and safety of practical uses of rivaroxaban in peri-procedure of catheter ablation in patients with non-valvular atrial fibrillation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Composite of thromboembolic events and major bleedings within 1 month since catheter ablation procedure

-Thromboembolic events; transient ischemic attack, ischemic stroke, non-CNS systemic embolism

- Major bleeding; pericardial effusion requiring a drainage procedure (cardiac tamponade),puncture hematoma requiring surgery, other bleeding episodes requiring blood transfusion, intracranial hemorrhage

Key secondary outcomes

- Thromboembolism within 1 month since catheter ablation procedure
- Major bleeding within 1 month since catheter ablation procedure
- Non-major bleeding within 1 month since catheter ablation procedure
- Composite of thromboembolism and major bleeding within 1 month since catheter ablation procedure in a group of patients for whom the oral anticoagulation therapy was interrupted on the day of catheter ablation (interrupted regimen group) and in another group for whom the oral anticoagulation therapy was administered on the day of catheter ablation procedure (uninterrupted regimen group)
- Non-major bleeding within 1 month since catheter ablation procedure in a group of patients for whom the oral anticoagulation therapy was interrupted on the day of catheter ablation (interrupted regimen group) and in another group for whom the oral anticoagulation therapy was administered on the day of catheter ablation (uninterrupted regimen group)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Non-valvular atrial fibrillation patients scheduled to undergo the catheter ablation procedure and to have been receiving rivaroxaban for at least 3 weeks at the time of admission for catheter ablation procedure

Key exclusion criteria

Patients for whom catheter ablation for atrial fibrillation is contraindicated

Patients with a history of thromboembolism or myocardial infarction within 2 months prior to enrollment

Target sample size

1100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Okumura

Organization

Hirosaki University Graduate School of Medicine

Division name

Department of Cardiology

Zip code


Address

5, Zaifu-cho, Hirosaki, Aomori, 036-8562 Japan

TEL

0172-33-5111

Email

okumura@cc.hirosaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Bell Medical Solutions, Inc.

Organization

Bell Medical Solutions, Inc.

Division name

Clinical Research and Development Division

Zip code


Address

Bunkyo Green Court, 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, JAPAN

TEL

0120-291-335

Homepage URL


Email

jimukyoku@medical-bs24.com


Sponsor or person

Institute

Reimeikyou

Institute

Department

Personal name



Funding Source

Organization

Bayer Yakuhin, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-16-0621/_article

Number of participants that the trial has enrolled


Results

The rates of thromboembolism and major bleeding events during the AF ablation perioperative period in Japanese patients treated with rivaroxaban was as low as in those treated with warfarin.

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



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 04 Month 21 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 16 Day

Last follow-up date

2015 Year 09 Month 15 Day

Date of closure to data entry

2015 Year 09 Month 20 Day

Date trial data considered complete

2015 Year 09 Month 30 Day

Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information

In the post-hoc analysis of rivaroxaban in the ROCKET AF study, no differences in the incidence rates of thromboembolism and hemorrhagic events after ablation compared to those after warfarin treatment were reported. However, these data were obtained from a limited number of patients, all with high CHADS2 risk scores, compared to the target patient population for ablation in actual clinical practice.
A recent registered observational study by Lakkireddy et al. reported that the efficacy and safety of the uninterrupted rivaroxaban after the evening meal and the uninterrupted Vitamin K antagonist were comparable.


Management information

Registered date

2014 Year 08 Month 11 Day

Last modified on

2016 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017087


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name