UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012858 |
|---|---|
| Receipt number | R000015008 |
| Scientific Title | The research for the adheerence and QOL for oral anti-coagulants(OAC) in patients with atrial fibrillation |
| Date of disclosure of the study information | 2014/01/15 |
| Last modified on | 2015/03/12 17:09:05 |
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Basic information
Public title
The research for the adheerence and QOL for oral anti-coagulants(OAC) in patients with atrial fibrillation
Acronym
The research for the adheerence and QOL for oral anti-coagulants(OAC) in patients with atrial fibrillation
Scientific Title
The research for the adheerence and QOL for oral anti-coagulants(OAC) in patients with atrial fibrillation
Scientific Title:Acronym
The research for the adheerence and QOL for oral anti-coagulants(OAC) in patients with atrial fibrillation
Region
| Japan |
Condition
Condition
atrial fibrillation(AF)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research the patient's satisfaction levels for rivaroxaban compared with other OACs, warfarin and dabigatran.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Investigation of patient characteristics.
Investigation of drug adhearence and needs in AF patients.
Investigation of unused medications in AF patients.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All the patients with non-valvular AF and a 3- to 6-month history of anticoagulation therapy who visit KKR group hospital berween October and Decenber 2013.
Key exclusion criteria
1.the patient dose not give consent to participation in this investigation.
2.the patient is ineligible for the investigation as judged by the attending physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Manabe |
Organization
KKR Takamatsu hospital
Division name
Department of Medicine
Zip code
Address
4-18, Tenjin-mae, Takamatsu-shi, Kagawa-ken
TEL
087-861-3261
rin-ken@kkr-ta-hp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Manabe |
Organization
KKR Takamatsu hospital
Division name
Department of Medicine
Zip code
Address
4-18, Tenjin-mae, Takamatsu-shi, Kagawa-ken
TEL
087-861-3261
Homepage URL
rin-ken@kkr-ta-hp.gr.jp
Sponsor or person
Institute
KKR Takamatsu hospital
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin,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
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
| 2014 | Year | 01 | Month | 15 | 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
| 2013 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 09 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 17 | Day |
Other
Other related information
prospective study
Management information
Registered date
| 2014 | Year | 01 | Month | 15 | Day |
Last modified on
| 2015 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015008
