UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009617 |
|---|---|
| Receipt number | R000011135 |
| Scientific Title | Registry of Japanese Patients with Atrial Fibrillation Focused on anticoagulant therapy in New Era:The RAFFINE Study |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2022/07/02 16:54:41 |
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Basic information
Public title
Registry of Japanese Patients with Atrial Fibrillation Focused on anticoagulant therapy in New Era:The RAFFINE Study
Acronym
Atrial fibrillation Patients Registry Study
Scientific Title
Registry of Japanese Patients with Atrial Fibrillation Focused on anticoagulant therapy in New Era:The RAFFINE Study
Scientific Title:Acronym
Atrial fibrillation Patients Registry Study
Region
| Japan |
Condition
Condition
Atrial Fibrillation
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We sought to describe contemporary treatment variation in Japanese clinical practice according to patient demographics, risk factors and size of medical provider. In addition, we examine how outcomes vary by stratified groups (especially types of anticoagulants).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy outcome: ischemic stroke or non-central nervous system systemic embolism
The safety outcome: major bleeding (ISTH bleeding criteria)
Key secondary outcomes
all-cause mortality, cardiovascular death, myocardial infarction, heart failure-related hospitalization,newly diagnosed cancer, non-major clinically relevant bleeding
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
Patients aged 20 years or older with a diagnosis of AF will be eligible for enrollment. We will enroll a consecutive series of AF patients of all types (paroxysmal, persistent and permanent) under regular clinical observation (longer than three months) in the outpatient clinic at each institution.
Key exclusion criteria
Patients who are hospitalized, anticipated life expectancy less than one year, without consent will be excluded in this study.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Daida |
Organization
Juntendo University School of Medicine
Division name
Department of Cardiology
Zip code
Address
2-1-1Hongo Bunkyo Tokyo
TEL
03-3813-3111
daida@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | takahama |
Organization
Juntendo University
Division name
Clinical reserch center
Zip code
Address
2-1-1 hongo bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
rinri@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Main results already published
Date of protocol fixation
| 2012 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicenter, prospective observational study
Management information
Registered date
| 2012 | Year | 12 | Month | 24 | Day |
Last modified on
| 2022 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011135
