UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027974
Receipt number 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 2022/07/02 10:26:54

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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 or person

Institute

Nihon University School of Pharmacy.

Institute

Department

Personal name



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

Value
https://center6.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