UMIN-CTR Clinical Trial

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
Email	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
Email	takahashi-yuichi@tc-clinic.jp

Sponsor
Institute	Medical Corporation Chiseikai Tokyo Center Clinic
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053229