UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063161 |
|---|---|
| Receipt number | R000072292 |
| Scientific Title | A Study of Cerebrovascular and Cardiovascular Events and Associated Healthcare Costs in Patients with Hypercholesterolemia |
| Date of disclosure of the study information | 2026/10/05 |
| Last modified on | 2026/10/03 15:57:10 |
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Basic information
Public title
A Study of Cerebrovascular and Cardiovascular Events and Associated Healthcare Costs in Patients with Hypercholesterolemia
Acronym
A Study of Cerebrovascular and Cardiovascular Events and Associated Healthcare Costs in Patients with Hypercholesterolemia
Scientific Title
A Study of Cerebrovascular and Cardiovascular Events and Associated Healthcare Costs in Patients with Hypercholesterolemia
Scientific Title:Acronym
A Study of Cerebrovascular and Cardiovascular Events and Associated Healthcare Costs in Patients with Hypercholesterolemia
Region
| Japan |
Condition
Condition
Hypercholesterolemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cumulative Incidence of Cardiovascular and Cerebrovascular Events and Direct Medical Costs in Patients with Hypercholesterolemia Receiving Secondary Prevention
Basic objectives2
Others
Basic objectives -Others
To determine the cumulative incidence of cardiovascular and cerebrovascular events according to the presence or absence of comorbidities, including diabetes mellitus, chronic kidney disease, and peripheral artery disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine the cumulative incidence of cardiovascular and cerebrovascular events and direct medical costs among patients with hypercholesterolemia in the secondary prevention population.
Key secondary outcomes
To determine the cumulative incidence of cardiovascular and cerebrovascular events according to the presence or absence of comorbidities, including diabetes mellitus, chronic kidney disease, and peripheral artery disease.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients hospitalized for a cardiovascular or cerebrovascular event, including ischemic stroke, myocardial infarction, stable angina, unstable angina, or transient ischemic attack.
2.Patients with no history of a cardiovascular or cerebrovascular event requiring hospitalization within the 6 months before the index hospitalization.
3.Patients aged 18 years or older at the time of the index hospitalization.
4.Patients with a recorded diagnosis of disorders of lipoprotein metabolism and other lipidemias (ICD-10 code E78) within 3 months before or after the index hospitalization.
5.Patients with an available low-density lipoprotein cholesterol (LDL-C) test result within 3 months before or after the index hospitalization.
Key exclusion criteria
1.Patients with a confirmed diagnosis of any cancer, liver cirrhosis, or dialysis status within 3 months before or after the index hospitalization. Suspected diagnoses will not be considered.
Target sample size
300000
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kondo |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Kondo.Tomohiro.a@otsuka.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kondo |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
Kondo.Tomohiro.a@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401 Mita, Minato-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.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
| 2026 | Year | 10 | Month | 05 | 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
230252
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
| 2025 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 05 | Month | 31 | Day |
Other
Other related information
To determine the cumulative incidence of cerebrovascular and cardiovascular events and the direct healthcare costs among secondary prevention patients with hypercholesterolemia.
Management information
Registered date
| 2026 | Year | 10 | Month | 03 | Day |
Last modified on
| 2026 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072292
