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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026912
Receipt No. 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

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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
Email 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
Email yumikonakano@okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital, Department of Neurology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030869

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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