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).

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.

• Authors: Naoki Saji, Takashi Sakurai, Kengo Ito, Hidekazu Tomimoto, Kazuo Kitagawa, Kaori Miwa, Yuji Tanaka, Koichi Kozaki, Kazuomi Kario, Masato Eto, Keisuke Suzuki, Atsuya Shimizu, Shumpei Niida, Akihiro Hirakawa, Kenji Toba, Strawberry study investigators
• Journal: BMJ open (BMJ Open) Vol. 8 Issue 11 Pg. e021759 (11 25 2018) ISSN: 2044-6055 [Electronic] England
• PMID: 30478106 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Antithrombins

Topics

• Activities of Daily Living
• Administration, Oral
• Aged, 80 and over
• Antithrombins (administration & dosage)
• Atrial Fibrillation (drug therapy)
• Cognitive Dysfunction (prevention & control)
• Dementia (prevention & control)
• Female
• Geriatric Assessment (methods)
• Humans
• Longitudinal Studies
• Male
• Multicenter Studies as Topic
• Observational Studies as Topic
• Prospective Studies
• Registries