UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024531
Receipt number R000028237
Scientific Title Survey regarding clinical and demographic characteristics of Japanese NVAF patient treated with warfarin and physicians treatment strategies to them in general practice.
Date of disclosure of the study information 2016/10/27
Last modified on 2018/03/28 07:30:50

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Basic information

Public title

Survey regarding clinical and demographic characteristics of Japanese NVAF patient treated with warfarin and physicians treatment strategies to them in general practice.

Acronym

SELECT study

Scientific Title

Survey regarding clinical and demographic characteristics of Japanese NVAF patient treated with warfarin and physicians treatment strategies to them in general practice.

Scientific Title:Acronym

SELECT study

Region

Japan


Condition

Condition

non-valvular artrial fibrillation

Classification by specialty

Cardiology Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1) to survey clinical and demographic characteristics in patients continuously treated with warfarin and those treated with apixaban and to identify the difference in characteristics if any.
2) to elucidate the reasons, both medical and non-medical ones, why physicians continue to use warfarin in some patients

Basic objectives2

Others

Basic objectives -Others

Survey on clinical and demographic characteristics in patients treated with warfarin and on general strategy of physician to use warfatin for treatement of non-valvular atrial patients

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

clinical and demographic characteristics in patients(at baseline)

Key secondary outcomes

general strategy of physician to use warfatin for treatement of non-valvular atrial patients


Base

Study type

Others,meta-analysis etc


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)Male or female subjects with age of 20 years or older
2)NVAF Patients treated with warfarin at least for 52 weeks for prevention of ischemic stroke and systemic embolism
3)Patients who have never been treated with any NOAC including apixaban

Key exclusion criteria

1)Patients who are prescribed warfarin for treatment of disease conditions other than for prevention of cardioembolic stroke or systemic embolism.
2)Patients with valvular AF.
3)Patients without definite diagnosis of NVAF
4)Patients whose warfarin treatment is initiated within 52 weeks before the baseline.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Motohiko Chachin

Organization

Pfizer Japan Inc.

Division name

Pfizer Innovative Health, Medical Affairs

Zip code


Address

3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan

TEL

080-3932-3402

Email

Motohiko.Chachin@pfizer.com


Public contact

Name of contact person

1st name
Middle name
Last name Tomomi Imai

Organization

Mebix Inc.

Division name

Clinical Research Division

Zip code


Address

Towers Office Toranomon, 4-1-28 Toranomon, Minato-ku, Tokyo 105-0001

TEL

03-4362-4504

Homepage URL


Email

select@mebix.co.jp


Sponsor or person

Institute

Pfizer Japan, inc.

Institute

Department

Personal name



Funding Source

Organization

Pfizer Japan, Inc.

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 10 Month 27 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/29398909

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

2016 Year 09 Month 28 Day

Date of IRB


Anticipated trial start date

2016 Year 11 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2017 Year 02 Month 20 Day

Date analysis concluded

2017 Year 03 Month 10 Day


Other

Other related information

1)After the execution of contract with an institution, index date is determined. Before the index date, 10 eligible patients who meet the enrollment criteria are retrospectively selected in a continuous manner. That is, physicians will not intentionally select the patients and consecutive patients are selected retrospectively from the date of contract execution if he or she is eligible.
2)Physicians also fill the questionnaire regarding general strategies for anticoagulant therapy of NVAF patients using warfarin at any time at the study period.


Management information

Registered date

2016 Year 10 Month 24 Day

Last modified on

2018 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028237


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name