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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009617
Receipt No. 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 2016/12/27

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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
Email 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
Email rinri@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Department of Cardiology
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2012 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
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
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011135

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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