UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026912 |
|---|---|
| Receipt number | R000030869 |
| Scientific Title | The observational study on efficacy of oral anticoagulants for cognitive dysfunctions of the patients after cerebral infarction in super-aged society |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2017/04/09 00:17:37 |
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Basic information
Public title
The observational study on efficacy of oral anticoagulants for cognitive dysfunctions of the patients after cerebral infarction in super-aged society
Acronym
The study on NOAC for prevention of dementia after stroke
Scientific Title
The observational study on efficacy of oral anticoagulants for cognitive dysfunctions of the patients after cerebral infarction in super-aged society
Scientific Title:Acronym
The study on NOAC for prevention of dementia after stroke
Region
| Japan |
Condition
Condition
non-valvular atrial fibrillation (NVAF)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the efficacy of NOAC (non-vitamin K antagonist oral anticoagulant) for reduction of a risk at cognitive dysfunction after cerebral infarction of the patients with NVAF.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the change of MMSE (mini-mental state examination) score between baseline and after 2 years of the registration
Key secondary outcomes
1) occurrences of death from any cause, dementia, stroke, and cardiovascular events
2) the change of CDR score
3) the change of MoCA score
4) occurrences of hemorrhagic events
5) occurrences of ischemic events
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) non-valvular atrial fibrillation
2) the use of oral anticoagulants (warfarin and NOACs)
3) CDR 0-0.5 and MMSE 24-30
4) informed consent is obtained
5) the age over 49 and under 100 year-old
6) the patients after cerebral infarction (over 6 months after the onset)
Key exclusion criteria
1) valvular atrial fibrillation
2) CDR>0.5 or MMSE<24
3) the patients after cerebral infarction (under 6 months after the onset)
4) Parkinson disease, Huntington disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, epilepsy, subdural hematoma, encephalitis/meningitis, multiple sclerosis, or cognitive decline by head trauma
5) depression, schizophrenia, alcoholism, drug dependence, or other critical disease
6) deficiency of vitamin B1, B12, or folic acid, syphilis, or hypothyroidism
7) difficult to perform the neuropsychological examination
8) other inappropriate state assessed by the researchers
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Abe |
Organization
Okayama University Hospital
Division name
Department of Neurology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7365
yumikonakano@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko Nakano |
Organization
Okayama University Hospital
Division name
Department of Neurology
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-235-7365
Homepage URL
yumikonakano@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital, Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | 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 | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will include the patients with non-valvular atrial fibrillation (NVAF) who are over 49 and under 100 year-old after 6 months of cerebral infarction and use the oral anticoagulants. We will compare the MMSE after 2 years of registration to baseline, and validate the reduction for a risk at cognitive dysfunction in these patients.
Management information
Registered date
| 2017 | Year | 04 | Month | 09 | Day |
Last modified on
| 2017 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030869
