UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034176 |
|---|---|
| Receipt number | 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 | 2020/09/18 09:47:17 |
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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 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
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
office_adherence@accerise.co.jp
Sponsor or person
Institute
Rakuwakai Otowa Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
