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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028754
Receipt No. R000032903
Scientific Title Silent cerebral microvascular disease and longitudinal risK of cognitive decline in Atrial Fibrillation study
Date of disclosure of the study information 2017/10/01
Last modified on 2017/10/02

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Basic information
Public title Silent cerebral microvascular disease and longitudinal risK of cognitive decline in Atrial Fibrillation study
Acronym SKAF Study
Scientific Title Silent cerebral microvascular disease and longitudinal risK of cognitive decline in Atrial Fibrillation study
Scientific Title:Acronym SKAF Study
Region
Japan

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

Objectives
Narrative objectives1 It is the examination that the onset of the asymptomatic cerebrovascular disorder in the non-valvular atrial fibrillation (NVAF) patient and the cognitive functional decline, and this study is a study of assume to examine the protective efficacy for them of Edoxaban more a main purpose, searching.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The onset of asymptomatic cerebrovascular disorder situation during the observation period
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 The patient who takes Edoxaban
Interventions/Control_2 The patient who does not take the anticoagulant
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) The patient who was given a definitive diagnosis of Non-valvular atrial fibrillation (NVAF) 60 years or older
(2) The patient who hasn't had a Cerebral infarction or a dementia in the past
(3) The patient that a written agreement was provided
Key exclusion criteria (1) The patient who participates in an intervention examination now or plans it
(2) The patient who is given a definitive diagnosis of mitral stenosis
(3) he patient who has an Artificial valve (aMachine valve or a Bioprosthetic valv)
(4) The patient who received art of heart intervention 1 month before enrolled
(5) The patient who contraindications of MRI inspection
(6) The patient who has a depression
(7) The patient who is remaining 2 years because of some diseases
(8) The patient who is inappropriateness of this study judged by the doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Kondo
Organization Chiba University Hospital
Division name cardiovascular medicine
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL 0432262847
Email shimokita9933@msn.com

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Kondo
Organization Chiba University Graduate School of Medicines
Division name Department of Advanced Cardiovascular Therapeutics
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL 0432262847
Homepage URL
Email shimokita9933@msn.com

Sponsor
Institute DAIICHI SANKYO COMPANY
Institute
Department

Funding Source
Organization Not appriciate
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
2017 Year 10 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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 11 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

Management information
Registered date
2017 Year 08 Month 21 Day
Last modified on
2017 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032903

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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