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Protective effects of oral anticoagulants on cerebrovascular diseases and cognitive impairment in patients with atrial fibrillation: protocol for a multicentre, prospective, observational, longitudinal cohort study (Strawberry study)
  1. Naoki Saji1,
  2. Takashi Sakurai1,2,
  3. Kengo Ito3,
  4. Hidekazu Tomimoto4,
  5. Kazuo Kitagawa5,
  6. Kaori Miwa6,
  7. Yuji Tanaka7,8,
  8. Koichi Kozaki9,
  9. Kazuomi Kario10,
  10. Masato Eto11,
  11. Keisuke Suzuki3,
  12. Atsuya Shimizu12,
  13. Shumpei Niida13,
  14. Akihiro Hirakawa14,
  15. Kenji Toba1
  16. on behalf of the Strawberry study investigators
  1. 1 Center for Comprehensive Care and Research on Memory Disorders, National Center for Geriatrics and Gerontology, Obu, Japan
  2. 2 Department of Cognition and Behavioural Science, Nagoya University Graduate School of Medicine, Nagoya, Japan
  3. 3 Innovation Center for Clinical Research, National Center for Geriatrics and Gerontology, Obu, Japan
  4. 4 Department of Neurology, Mie University Graduate School of Medicine, Tsu, Japan
  5. 5 Department of Neurology, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan
  6. 6 Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan
  7. 7 Department of Neurology, Gifu Municipal Hospital, Gifu, Japan
  8. 8 Health Service Center, Aichi University of Education, Kariya, Japan
  9. 9 Department of Geriatric Medicine, Kyorin University School of Medicine, Tokyo, Japan
  10. 10 Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan
  11. 11 International Research Center for Medical Education, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
  12. 12 Department of Cardiology, National Center for Geriatrics and Gerontology, Obu, Japan
  13. 13 Medical Genome Center, National Center for Geriatrics and Gerontology, Obu, Japan
  14. 14 Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
  1. Correspondence to Dr Naoki Saji; sajink{at}nifty.com

Abstract

Introduction Non-valvular atrial fibrillation (NVAF) is known as a robust risk factor for stroke. Recent reports have suggested a risk of dementia with NVAF, but much remains unknown regarding the relationship between this mechanism and the potential protective effects of novel anticoagulants (direct oral anticoagulants (DOACs), or non-vitamin K oral anticoagulants).

Methods and analysis This study, the strategy to obtain warfarin or DOAC’s benefit by evaluating registry, is an investigator-initiated, multicentre, prospective, observational, longitudinal cohort study comparing the effects of warfarin therapy and DOACs on cerebrovascular diseases and cognitive impairment over an estimated duration of 36 months. Once a year for 3 years, the activities of daily living and cognitive functioning of non-demented patients with NVAF will be assessed. Demographics, risk factors, laboratory investigations, lifestyle, social background and brain MRI will be assessed.

Ethics and dissemination This protocol has been approved by the ethics committee of the National Center for Geriatrics and Gerontology (No. 1017) and complies with the Declaration of Helsinki. Informed consent will be obtained before study enrolment and only coded data will be stored in a secured database. The results will be published in peer-reviewed journals and presented at scientific meetings to ensure the applicability of the findings in clinical practice.

Trial registration number UMIN000025721.

  • atrial fibrillation
  • cerebrovascular diseases
  • cognitive impairment
  • dementia
  • stroke

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors NS is the principle investigator and contributed to the concept, drafting and design of the protocol. TS, KI, HT, KK, KM, YT, KK, KK, ME, KS, AS, SN, AH and KT contributed to the design of the study and reviewed the manuscript for intellectual content.

  • Funding This work was supported by Research Funding of Longevity Sciences (28-15, 30-1) from the National Center for Geriatrics and Gerontology, the Japan Foundation for Aging and Health, The BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program and the Funds for Research and Development Grants for Longevity Science from the Japan Agency for Medical Research and Development.

  • Disclaimer The sponsors have no role in the study design and conduct; the collection, management, analysis and interpretation of the data; or the preparation and approval of the manuscript.

  • Competing interests NS reports grants from Research Funding of Longevity Sciences from the National Center for Geriatrics and Gerontology, grants from Japan Foundation for Aging and Health, grants from the BMS/Pfizer Japan Thrombosis Investigator Initiated Research Program, grants from Funds for Research and Development Grants for Longevity Science from the Japan Agency for Medical Research and Development.

  • Patient consent Not required.

  • Ethics approval The study was approved by the Institutional Review Board of the National Center for Geriatrics and Gerontology (No. 1017). This study was registered with the UMIN Clinical Trials Registry (UMIN000025721).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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