UMIN-CTR Clinical Trial

Basic information
Public title	Survey on Medication Adherence to Direct Oral Anticoagulants in Patients with Non-Valvular Atrial Fibrillation (NVAF)
Acronym	Survey on Medication Adherence to DOACs in NVAF
Scientific Title	Survey on Medication Adherence to Direct Oral Anticoagulants in Patients with Non-Valvular Atrial Fibrillation (NVAF)
Scientific Title:Acronym	Survey on Medication Adherence to DOACs in NVAF
Region	Japan

Condition
Condition	Non-Valvular Atrial Fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To survey the patients' level of insights into disease and medication regarding anticoagulant therapy, medication instructions, medication adherence to direct oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation (NVAF) under routine clinical practice.
Basic objectives2	Others
Basic objectives -Others	To investigate the factors affecting medication adherence to DOACs.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Percentage of DOACs with correct dosing 2)Rate of non-adherent patients to DOACs 3)Exploration of factors influencing adherence
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who have received the same DOAC (Apixaban, Edoxaban, Dabigatran, Rivaroxaban) for 3 months or more when giving consent 2) Patients who are prescribed DOAC for 28 days or more or 99 days or less on date of the consent 3) Patients who provide written consents by themselves in response to the explanation of this study
Key exclusion criteria	1)Patients who aged less than 20 years of age 2)Patients currently participating or scheduled to participate in intervention studies 3)Patients hospitalized or expected to be hospitalized during participation in the study 4)Patients with adjustment of quantity in the prescription due to unused drugs patients own 5)Patients whose prescription is divided in more than twice 6)Any patients who are deemed inappropriate by research director or co-investigators
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Miura
Organization	Rakuwakai Otowa Hospital
Division name	Pharmaceutical department
Zip code	607-8062
Address	2 Otowa, Chinji-cho, Yamashina-ku, Kyoto, Japan
TEL	81-75-593-4111
Email	miura_m@rakuwa.or.jp

Public contact
Name of contact person	1st name accerise.Inc. Middle name Last name Adherence Contact Office
Organization	accerise.Inc.
Division name	CRO Div.
Zip code	101-0052
Address	1-11 Kanda-Ogawamachi, Chiyoda-ku, Tokyo
TEL	03-5577-3872
Homepage URL
Email	office_adherence@accerise.co.jp

Sponsor
Institute	Rakuwakai Otowa Hospital
Institute
Department

Funding Source
Organization	Medical Science Department Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	NA
Address	NA
Tel	NA
Email	NA

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

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 25 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
Results
Results date posted
Results Delayed
Results Delay Reason
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	Completed
Date of protocol fixation	2018 Year 08 Month 02 Day
Date of IRB	2018 Year 08 Month 08 Day
Anticipated trial start date	2018 Year 09 Month 25 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multicenter Prospective Observational Study

Management information
Registered date	2018 Year 09 Month 18 Day
Last modified on	2020 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038965