UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025721
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email strawberry@ncgg.go.jp

Sponsor
Institute Center for Comprehensive Care and Research on Memory Disorders, National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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
URL(English) https://upload.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


Contact us.