UMIN-CTR Clinical Trial

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

non-valvular artrial fibrillation

Classification by specialty

Cardiology

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Pfizer Japan, inc.

Institute

Department

Personal name

Organization

Pfizer Japan, Inc.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

27

Day

URL releasing protocol

Publication of results

Published

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

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 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.

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