UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046687 |
|---|---|
| Receipt number | R000053229 |
| Scientific Title | A Clinical study in patients with dyslipidemia to determine the status of recognition and the percentage of patients achieving the target values for the management of each lipid parameter specified in the Japan Atherosclerosis Society Guidelines for the Prevention of Atherosclerotic Cardiovascular Diseases (2022 edition), and to follow-up the achievement of the target values by subsequent treatment approaches. |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/09/30 09:36:14 |
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Basic information
Public title
A Clinical study in patients with dyslipidemia to determine the status of recognition and the percentage of patients achieving the target values for the management of each lipid parameter specified in the Japan Atherosclerosis Society Guidelines for the Prevention of Atherosclerotic Cardiovascular Diseases (2022 edition), and to follow-up the achievement of the target values by subsequent treatment approaches.
Acronym
A Clinical study in patients with dyslipidemia to determine the status of recognition and the percentage of patients achieving the target values for the management of each lipid parameter specified in the Japan Atherosclerosis Society Guidelines for the Prevention of Atherosclerotic Cardiovascular Diseases (2022 edition), and to follow-up the achievement of the target values by subsequent treatment approaches.
Scientific Title
A Clinical study in patients with dyslipidemia to determine the status of recognition and the percentage of patients achieving the target values for the management of each lipid parameter specified in the Japan Atherosclerosis Society Guidelines for the Prevention of Atherosclerotic Cardiovascular Diseases (2022 edition), and to follow-up the achievement of the target values by subsequent treatment approaches.
Scientific Title:Acronym
A Clinical study in patients with dyslipidemia to determine the status of recognition and the percentage of patients achieving the target values for the management of each lipid parameter specified in the Japan Atherosclerosis Society Guidelines for the Prevention of Atherosclerotic Cardiovascular Diseases (2022 edition), and to follow-up the achievement of the target values by subsequent treatment approaches.
Region
| Japan |
Condition
Condition
Dyslipidemia
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the actual status of recognition of the lipid management target values set in the Guidelines for the Prevention of Arteriosclerotic Disease (2022 edition) (notification from medical institutions and physicians, use of the guidelines during medical care, etc.) and the percentage of patients achieving the management target values among dyslipidemia patients at high risk of recurrence or development of arteriosclerotic disease within 10 years. In addition, we will observe the effects on lipid parameters as a result of the treatment approach that involves recognition of the target values and communication of the medical significance and necessity of achieving the target values.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To understand the recognition status of lipid management target values at the time of obtaining consent and the actual percentage of patients achieving lipid management target values. The amount of change in lipid parameters (LDLC (mg/dl), HDL-C (mg/dl), Non-HDL-C (mg/dl), TG (mg/dl)) set as lipid management targets and the percentage of patients achieving lipid management targets.
Key secondary outcomes
Changes in amount of blood pressure and body weight
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)Men and women aged 18 and over
2)A history of atherosclerotic cardiovascular disease(angina pectoris, myocardial infarction,cerebral infarction,or symptomatic peripheral arterial disease)in the past 10 years
3)LDL-C between 70 and 240 mg/dl at Visit 1 (pre-SCR)
4)Patients with dyslipidemia
Key exclusion criteria
1)Triglyceride level over 400 mg/dl at Visit 1(pre-SCR)
2)A history of malignant tumor within 5 years before screening
3)Persons deemed ineligible by the study physician
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Takahashi |
Organization
Medical Corporation Chiseikai
Tokyo Center Clinic
Division name
Clinical Research Group
Zip code
1030028
Address
Yaesu KT Building 2F, 1-1-8, Yaesu, Chuo-ku, Tokyo
TEL
0332766935
takahashi-yuichi@tc-clinic.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Takahashi |
Organization
Medical Corporation Chiseikai Tokyo Center Clinic
Division name
Clinical Research Group
Zip code
1030028
Address
Yaesu KT Building 2F, 1-1-8, Yaesu, Chuo-ku, Tokyo
TEL
0332766935
Homepage URL
takahashi-yuichi@tc-clinic.jp
Sponsor or person
Institute
Medical Corporation Chiseikai
Tokyo Center Clinic
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-profit organization Tokyo Allergy and Respiratory Disease Research Institute
Address
Riverside Tower Kuramae 3F, 1-8-6 Kuramae,Taito-ku,Tokyo
Tel
080-7360-0910
info@inclusion-p.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
東京センタークリニック（東京都）
TOKYO CENTER CLINIC (TOKYO)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | 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
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
Terminated
Date of protocol fixation
| 2021 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 01 | Month | 21 | Day |
Last modified on
| 2022 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053229
