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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027974
Receipt No. R000032041
Scientific Title Utilization and its Impact on the Effects of Oral Anticoagulants using Japanese National Database of Health Insurance Claims.
Date of disclosure of the study information 2017/07/01
Last modified on 2019/07/03

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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 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 No longer recruiting
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
2020 Year 08 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2017 Year 06 Month 28 Day
Last modified on
2019 Year 07 Month 03 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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