UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001569 |
|---|---|
| Receipt number | 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 11:35:27 |
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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
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
jr-registry@nms.ac.jp
Sponsor or person
Institute
The Japanese Society of Electrocardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001772
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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