UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028754 |
|---|---|
| Receipt number | 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 19:08:53 |
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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
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
shimokita9933@msn.com
Sponsor or person
Institute
DAIICHI SANKYO COMPANY
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032903
