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
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
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
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
