UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survey regarding clinical and demographic characteristics of Japanese NVAF patient treated with warfarin and physicians treatment strategies to them in general practice.
Title of the study (Brief title)	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	Motohiko Chachin
Organization	Pfizer Japan Inc.
Division name	Pfizer Innovative Health, Medical Affairs
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	Tomomi Imai
Organization	Mebix Inc.
Division name	Clinical Research Division
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
Institute	Pfizer Japan, inc.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/29398909
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028237