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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034176
Receipt No. R000038965
Scientific Title Survey on Medication Adherence to Direct Oral Anticoagulants in Patients with Non-Valvular Atrial Fibrillation (NVAF)
Date of disclosure of the study information 2018/09/25
Last modified on 2019/03/25

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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 90 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 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Miura
Organization Rakuwakai Otowa Hospital
Division name Pharmaceutical department
Zip code
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
Middle name
Last name Adherence Contact Office
Organization accerise.Inc.
Division name CRO Div.
Zip code
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
Address
Tel
Email

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 Open public recruiting
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
2019 Year 03 Month 25 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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