UMIN-CTR Clinical Trial

Basic information
Public title	Utilization and its Impact on the Effects of Oral Anticoagulants using Japanese National Database of Health Insurance Claims.
Acronym	Utilization and its Impact on the Effects of Oral Anticoagulants.
Scientific Title	Utilization and its Impact on the Effects of Oral Anticoagulants using Japanese National Database of Health Insurance Claims.
Scientific Title:Acronym	Utilization and its Impact on the Effects of Oral Anticoagulants.
Region	Japan

Condition
Condition	Atrial fibrillation
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To describe utilization of oral anticoagulants and examine its impact(particularly, possible underdosing)on the effects of anticoagulants in Japan.
Basic objectives2	Others
Basic objectives -Others	Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hospitalization due to stroke, myocardial infarction, systemic embolism, or bleeding.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with the first record of prescribing/dispensing of an oral anticoagulant after at least one-year of non-use.
Key exclusion criteria	1.Patients younger than 20 years old when an anticoagulant was first prescribed. 2.Patients without diagnosis code of non-valvular AF. 3.Patients with diagnosis code of coagulation deficiency.
Target sample size	400000

Research contact person
Name of lead principal investigator	1st name Nobuhiro Middle name Last name Ooba
Organization	Nihon University School of Pharmacy.
Division name	Department of Clinical Pharmacy.
Zip code	274-8555
Address	7-7-1 Narashinodai, Funabashi, Chiba
TEL	047-465-3548
Email	ooba.nobuhiro@nihon-u.ac.jp

Public contact
Name of contact person	1st name Nobuhiro Middle name Last name Ooba
Organization	Nihon University School of Pharmacy.
Division name	Department of Clinical Pharmacy.
Zip code	274-8555
Address	7-7-1 Narashinodai, Funabashi, Chiba
TEL	047-465-3548
Homepage URL
Email	ooba.nobuhiro@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Pharmacy.
Institute
Department

Funding Source
Organization	Nihon University School of Pharmacy.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihon university School of Pharmacy
Address	7-7-1,Narashinodai, Funabashi-shi, Chiba
Tel	047-465-3548
Email	ooba.nobuhiro@nihon-u.ac.jp

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	2017 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	944776
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 10 Month 20 Day
Date of IRB	2016 Year 09 Month 14 Day
Anticipated trial start date	2017 Year 05 Month 12 Day
Last follow-up date	2021 Year 08 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 08 Month 22 Day

Other
Other related information	None

Management information
Registered date	2017 Year 06 Month 28 Day
Last modified on	2022 Year 07 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032041