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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Atrial fibrillation | ||
Classification by specialty |
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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 | |
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Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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Target sample size | 400000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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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 |