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
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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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