UMIN-CTR Clinical Trial

Basic information
Public title	Study on Single Nucleotide Polymorphisms of Functional Proteins determining Absorption, Metabolism, and Excretion of Edoxaban.
Acronym	Single Nucleotide Polymorphisms and Edoxaban.
Scientific Title	Study on Single Nucleotide Polymorphisms of Functional Proteins determining Absorption, Metabolism, and Excretion of Edoxaban.
Scientific Title:Acronym	Single Nucleotide Polymorphisms and Edoxaban.
Region	Japan

Condition
Condition	Non-valvular atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Pharmacological potency, side effect, and kinetics in body are influenced by single nucleotide polymorphisms of genes encoding key proteins controlling drug's absorption, metabolism and excretion. This study aims to examine the effect of these functional SNPs on edoxaban blood level and to consider the precision medicine to avoid its side effect.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Examine the relationship between functional SNP in CYP3A5, ABCB1 and ABCG2 and blood levels of oral edoxaban and determine their influence.
Key secondary outcomes

Base
Study type	Observational

Study design
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Concealment

Intervention
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Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with non-valvular atrial fibrillation receiving oral edoxaban therapy
Key exclusion criteria	Those who cannot give informed consent Patients younger than 20 years
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Minoru Horie
Organization	Shiga University of Medical Sciences
Division name	Department of Cardiovascular Medicine
Zip code
Address	Tsukinowa-Seta, Ohtsu City
TEL	81-77-548-2213
Email	horie@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Ashihara
Organization	Shiga University of Medical Sciences
Division name	Department of Cardiovascular Medicine
Zip code
Address	Tsukinowa-Seta, Ohtsu City
TEL	81-77-548-2213
Homepage URL
Email	tashihar@gmail.com

Sponsor
Institute	Department of Cardiovascular Medicine Shiga University of Medical Sciences
Institute
Department

Funding Source
Organization	Daiichi Sankyo CO, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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IRB Contact (For public release)
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Secondary IDs
Secondary IDs	NO
Study ID_1
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Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 08 Month 14 Day
Date of IRB	2017 Year 08 Month 14 Day
Anticipated trial start date	2017 Year 12 Month 01 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry	2021 Year 06 Month 30 Day
Date trial data considered complete	2021 Year 06 Month 30 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other

Other related information

Preliminary study on apixaban metabolism was published this year. Ueshima S et al. Impact of ABCB1, ABCG2, and CYP3A5 polymorphisms on plasma trough concentrations of apixaban in Japanese patients with atrial fibrillation. Pharmacogenet Genomics. 2017 Sep;27(9):329-336. Part of the result from this study (SiDOAC-SNP) will be presented at the 84th Annual Meeting of Japanese Circulation Society (Kyoto).

Management information
Registered date	2017 Year 08 Month 29 Day
Last modified on	2020 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033058