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

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 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


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

Value
https://center6.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