UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The observational study on efficacy of oral anticoagulants for cognitive dysfunctions of the patients after cerebral infarction in super-aged society
Title of the study (Brief title)	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	Koji Abe
Organization	Okayama University Hospital
Division name	Department of Neurology
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	Yumiko Nakano
Organization	Okayama University Hospital
Division name	Department of Neurology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 04 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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