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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001569
Receipt No. R000001772
Scientific Title A multicenter study on warfarin use and optimal anticoagulation levels for prevention of cardiogenic embolism in Japanese patients with atrial fibrillation: J-RHYTHM Registry
Date of disclosure of the study information 2009/01/05
Last modified on 2013/09/10

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Basic information
Public title A multicenter study on warfarin use and optimal anticoagulation levels for prevention of cardiogenic embolism in Japanese patients with atrial fibrillation: J-RHYTHM Registry
Acronym J-RHYTHM Registry
Scientific Title A multicenter study on warfarin use and optimal anticoagulation levels for prevention of cardiogenic embolism in Japanese patients with atrial fibrillation: J-RHYTHM Registry
Scientific Title:Acronym J-RHYTHM Registry
Region
Japan

Condition
Condition atrial fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the present status of warfarin use and establish adequate intensity of PT-INR in Japanese patients with atrial fibrillation.
Basic objectives2 Others
Basic objectives -Others Registration and follow-up
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Investigation of clinical background at the development of following clinical event; symptomatic cerebral infarction, systemic embolism, major bleeding, all cause of death Optimal PT-INR for Japanese patients with atrial fibrillation
Key secondary outcomes Preventive effects of various medications including warfarin, antithrombotics drugs and others for the treatment of Japanese patients with atrial fibrillation

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria all patient with atrial fibrillation accepted the informal consent
Key exclusion criteria inadequate patients judged by their physician
Target sample size 6000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Inoue
Organization University of Toyama
Division name Second Department of Internal Medicine
Zip code
Address 2630 Sugitani Toyama-shi, Toyama
TEL 076-434-2281
Email hiroshi@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Atarashi
Organization Nippon Medical School Tama-Nagayama Hospital
Division name Internal Medicine
Zip code
Address 1-7-1 Nagayama Tama-shi, Tokyo
TEL 042-371-2111
Homepage URL
Email jr-registry@nms.ac.jp

Sponsor
Institute The Japanese Society of Electrocardiology
Institute
Department

Funding Source
Organization Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 01 Month 05 Day

Related information
URL releasing protocol http://www.sciencedirect.com/science/article/pii/S0914508710001784
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prevalence of warfarin use in Japanese AF patients, evaluation of recommended PT-INR in Japanese AF patient

Management information
Registered date
2008 Year 12 Month 12 Day
Last modified on
2013 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001772

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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