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Recruitment status Completed
Unique ID issued by UMIN UMIN000014817
Receipt No. 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

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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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute Reimeikyou
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017087


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