UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063514 |
|---|---|
| Receipt number | R000072652 |
| Scientific Title | An Exploratory Study on the Association Between C-Reactive Protein (CRP) and Cardiovascular Events in Japanese Patients with Hypercholesterolemia, and Its Relationship with Patient Background Factors |
| Date of disclosure of the study information | 2026/11/04 |
| Last modified on | 2026/11/04 17:22:19 |
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Basic information
Public title
An Exploratory Study on the Association Between C-Reactive Protein (CRP) and Cardiovascular Events in Japanese Patients with Hypercholesterolemia, and Its Relationship with Patient Background Factors
Acronym
An Exploratory Study on the Association Between C-Reactive Protein (CRP) and Cardiovascular Events in Japanese Patients with Hypercholesterolemia, and Its Relationship with Patient Background Factors
Scientific Title
An Exploratory Study on the Association Between C-Reactive Protein (CRP) and Cardiovascular Events in Japanese Patients with Hypercholesterolemia, and Its Relationship with Patient Background Factors
Scientific Title:Acronym
An Exploratory Study on the Association Between C-Reactive Protein (CRP) and Cardiovascular Events in Japanese Patients with Hypercholesterolemia, and Its Relationship with Patient Background Factors
Region
| Japan |
Condition
Condition
Hypercholesterolemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The association between CRP and CV events in patients with a history of atherosclerotic cardiovascular disease (ASCVD) who have hypercholesterolemia. Patient background factors associated with CRP.
Basic objectives2
Others
Basic objectives -Others
To association patient-related factors associated with CRP in patients with hypercholesterolemia who have no history of atherosclerotic cardiovascular disease (ASCVD).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of MACE in Patients with Hypercholesterolemia and a History of ASCVD in Japan: A Comparison Between Groups with High and Low CRP Levels, and Patient Background Factors Associated with High CRP Levels
Key secondary outcomes
Patient Background Factors Associated with High CRP Levels Among Japanese Patients with Hypercholesterolemia Without a History of ASCVD
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
Patients with hypercholesterolemia and a history of ASCVD
1. Patients with a documented diagnosis of ASCVD
2. Patients who were prescribed hypercholesterolemia medication within 3 months of the onset of ASCVD
3. Patients for whom CRP was measured at least once within 6 months after the prescription of hypercholesterolemia treatment
4. Patients aged 18 years or older as of the index date
5. Patients for whom the prescription of hypercholesterolemia treatment had continued up to the index date
Patients with hypercholesterolemia and no history of ASCVD
1. Patients for whom a prescription for hypercholesterolemia treatment had been initiated
2. Patients whose CRP was measured at least once within 6 months of the start of hypercholesterolemia treatment
3. Patients with no recorded diagnosis of ASCVD prior to the index date
4. Patients who were observable for the 1-year period prior to the index date
5. Patients aged 18 years or older as of the index date
6. Patients for whom the prescription of hypercholesterolemia treatment medication continued through the index date
Key exclusion criteria
1. Patients who were prescribed an IL-6 inhibitor during the patient background assessment period.
2. Patients who underwent an organ transplant during the patient background assessment period.
3. Patients with a recorded diagnosis of severe lower-limb ischemia prior to the Index Date
Target sample size
62000
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Matsukawa |
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
Matsukawa.Miyuki@otsuka.jp
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Okada |
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
Okada.Akane@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 Research Ethics Committee
Address
ST Shibuya Building 2F, 1-15-14 Dogenzaka, Shibuya-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 | 11 | Month | 04 | 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
62000
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
| 2026 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2026 | Year | 11 | Month | 04 | Day |
Last modified on
| 2026 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072652
