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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012858
Receipt No. 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

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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
Email 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
Email rin-ken@kkr-ta-hp.gr.jp

Sponsor
Institute KKR Takamatsu hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015008

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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