UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011135