UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025721 |
|---|---|
| Receipt number | R000029594 |
| Scientific Title | Strategy to obtain warfarin or direct oral anticoagulant's benefit by evaluating registry: Strawberry study |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2020/07/31 09:47:17 |
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Basic information
Public title
Strategy to obtain warfarin or direct oral anticoagulant's benefit by evaluating registry: Strawberry study
Acronym
Strategy to obtain warfarin or direct oral anticoagulant's benefit by evaluating registry: Strawberry study
Scientific Title
Strategy to obtain warfarin or direct oral anticoagulant's benefit by evaluating registry: Strawberry study
Scientific Title:Acronym
Strategy to obtain warfarin or direct oral anticoagulant's benefit by evaluating registry: Strawberry study
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology | Neurology |
| Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify oral anticoagulant use by patients with non-valvular atrial fibrillation (NVAF) and ascertain its effect on cerebrovascular disorders and cognitive dysfunction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in MMSE from time of enrollment until 3 years after enrollment
Key secondary outcomes
1. Change in Montreal Cognitive Assessment (MoCA) from time of enrollment until 3 years after enrollment
2. Time until occurrence of any death, stroke, or cardiovascular event
3. Change in CDR global score from time of enrollment until 3 years after enrollment
4. Change in Clinical Dementia Rating Sum of Boxes (CDR-SB) score from time of enrollment
Time until hemorrhagic or ischemic event
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with NVAF who:
1. are taking an oral anticoagulant at the time of enrollment
2. can undergo a brain magnetic resonance imaging (MRI) at the time of enrollment
3. have provided informed consent in writing
4. are between the ages of 40 and 84 years at the time of enrollment
5. have a Clinical Dementia Rating (CDR) global score of 0 to 0.5 and a Mini-Mental State Examination (MMSE) score of 20 to 30
6. and are accompanied by a study partner (someone who knows how the patient lives)
Key exclusion criteria
1. Patients with valvular atrial fibrillation
2. Patients unable to undergo MRI examination, or MRI cannot be evaluated due to body movement, etc.
3. Patients with dementia with a CDR global score greater than or equal to 1 or MMSE less than 20
4. 6 months or less since occurrence of stroke
5. Less than or equal to 6 years of education
6. Judged by an investigator to be ineligible to participate as a study subject
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Saji |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Comprehensive Care and Research on Memory Disorders
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi 474-8511 Japan
TEL
0562-46-2311
sajink@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Saji |
Organization
Center for Comprehensive Care and Research on Memory Disorders, National Center for Geriatrics and G
Division name
Strawberry Registry Secretariat
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi 474-8511 Japan
TEL
0562-46-2311
Homepage URL
https://strawberry.sbcs.jp
strawberry@ncgg.go.jp
Sponsor or person
Institute
Center for Comprehensive Care and Research on Memory Disorders, National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
The BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program; Japan Foundation for Aging and Health; Research Funding of Longevity Sciences from the NCGG
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430, Morioka, Obu, Aichi 474-8511 Japan
Tel
0562-46-2311
strawberry@ncgg.go.jp
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
研究参加予定施設 （※施設五十音順）
1. 一宮西病院 神経内科 （愛知県）
2. 大阪大学大学院医学系研究科 神経内科学 （大阪府）
3. 大阪大学大学院医学系研究科 老年・総合内科学 （大阪府）
4. 岡山大学大学院医歯薬学総合研究科 脳神経内科学 （岡山県）
5. 鹿児島大学大学院医歯学総合研究科 心臓血管・高血圧内科学 （鹿児島県）
6. 金沢医科大学 高齢医学科 （石川県）
7. 川崎医科大学 神経内科学 （岡山県）
8. 岐阜市民病院 神経内科 （岐阜県）
9. 杏林大学医学部 高齢医学 （東京都）
10. 高知大学医学部 老年病・循環器内科学 （高知県）
11. 国立長寿医療研究センター もの忘れセンター （愛知県）
12. 自治医科大学 循環器内科学 （栃木県）
13. 自治医科大学 神経内科学 （栃木県）
14. 千葉大学大学院医学研究院 細胞治療内科学 （千葉県）
15. 中部ろうさい病院 神経内科 （愛知県）
16. 東京大学大学院医学系研究科 加齢医学講座 （東京都）
17. 東京女子医科大学 神経内科 （東京都）
18. 東京都健康長寿医療センター 循環器内科 （東京都）
19. 東京都健康長寿医療センター 糖尿病・代謝・内分泌内科 （東京都）
20. 長崎大学 脳神経内科 （長崎県）
21. 名古屋大学大学院医学系研究科 地域在宅医療学・老年科学分野 （愛知県）
22. 名古屋市立東部医療センター 神経内科 （愛知県）
23. 兵庫県立姫路循環器病センター 高齢者脳機能治療室 （兵庫県）
24. 兵庫県立姫路循環器病センター 循環器内科 （兵庫県）
25. 藤田保健衛生大学 認知症・高齢診療科 （愛知県）
26. 三重大学大学院医学系研究科 神経病態内科学 （三重県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | 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
235
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because of a delay of data cleaning
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
in preparation
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2020 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029594
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/07/31 | UMIN_protocol_ver2.1.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/07/31 | UMIN_specification_strawberry.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/07/31 | UMIN_registration1.xlsx |
