UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052198 |
|---|---|
| Receipt number | R000059569 |
| Scientific Title | Survey of Changes in Antiplatelet Therapy Based on Japanese Insurance Claims Database |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2025/01/29 13:57:21 |
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Basic information
Public title
Survey of Changes in Antiplatelet Therapy Based on Japanese Insurance Claims Database
Acronym
Survey of Changes in Antiplatelet Therapy Based on Japanese Insurance Claims Database
Scientific Title
Survey of Changes in Antiplatelet Therapy Based on Japanese Insurance Claims Database
Scientific Title:Acronym
Survey of Changes in Antiplatelet Therapy Based on Japanese Insurance Claims Database
Region
| Japan |
Condition
Condition
ischemic cerebrovascular disorder (ICD) patients and ischemic heart disease (IHD) patients
Classification by specialty
| Cardiology | Neurology | Vascular surgery |
| Neurosurgery | Cardiovascular surgery | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to clarifying the changes in antiplatelet therapy, the actual condition of prescription for ICD patients and IHD patients is investigated using Japanese insurance claims database.
Basic objectives2
Others
Basic objectives -Others
The proportion of prescribing antiplatelet agents
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prescription status of antiplatelet agents at the index date and every three months for two years after the index date
(The proportion of prescribing antiplatelet agents, dual antiplatelet therapy (DAPT) and single antiplatelet therapy (SAPT))
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(Time of patient enrollment)
Phase A 2015, Phase B 2017, Phase C 2019
(ICD cohort)
1.Patients who received antiplatelet agents during the inclusion period of each phase. The index date is the start date of prescription.
2.Patients with a diagnosis of imaging and cerebral infarction on the index date.
(IHD cohort)
1.Patients with a procedure code of percutaneous coronary intervention (PCI) during the inclusion period of each phase. The index date is the first date of PCI.
2.Patients who received antiplatelet agents the index date.
Key exclusion criteria
(ICD cohort)
1.Patients with antiplatelet prescriptions during baseline period (between 5 months prior to the index date and the index date).
2.Patients with anticoagulant prescriptions between the start of baseline period and the end of the observation period.
3.Patients with indication for anticoagulation therapy (medical history of atrial fibrillation, persistent or paroxysmal atrial fibrillation, and prosthetic heart valve placement).
(IHD cohort)
1.Patients with antiplatelet prescriptions between the start of baseline period and 2 weeks prior to the index date.
2.Patients with anticoagulant prescriptions between the start of baseline period and the end of the observation period.
3.Patients with indication for anticoagulation therapy (medical history of atrial fibrillation, persistent or paroxysmal atrial fibrillation, and prosthetic heart valve placement).
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kimura |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
kimura.tetsuya.d2@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Sugimoto |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Primary Medical Science Department
Zip code
103-8426
Address
3-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1111
Homepage URL
sugimoto.masako.ny@daiichisankyo.co.jp
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3, Kichijoji-kitamachi, Musashino-shi, Tokyo, 180-0001, Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2023 | Year | 09 | Month | 15 | 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
47059
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
| 2023 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 02 | Month | 28 | Day |
Other
Other related information
A cohort study using the insurance claims database
Management information
Registered date
| 2023 | Year | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059569
