UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056716 |
|---|---|
| Receipt number | R000063807 |
| Scientific Title | Effect of lipid management treatment flow on patients with coronary artery disease: A multicenter, open-label, prospective, single-arm intervention study (Yokohama Coronary Lipid Study: YCLS) |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/15 13:20:56 |
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Basic information
Public title
Effect of lipid management treatment flow on patients with coronary artery disease
Acronym
Yokohama Coronary Lipid Study: YCLS
Scientific Title
Effect of lipid management treatment flow on patients with coronary artery disease: A multicenter, open-label, prospective, single-arm intervention study (Yokohama Coronary Lipid Study: YCLS)
Scientific Title:Acronym
Yokohama Coronary Lipid Study: YCLS
Region
| Japan |
Condition
Condition
Coronary artery disease, hypercholesterolemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the secondary prevention of patients with coronary artery disease, the European Society of Cardiology's "Guidelines for the Management of Dyslipidemia 2019" set the management goal as "an LDL-C reduction of >=50% from baseline and LDL-C < 55 mg/dL." In this study, we will examine whether the achievement rate of LDL-C < 70 mg/dL will be improved by introducing a lipid management treatment flow with the management goal of "an LDL-C reduction of >=50% from baseline and LDL-C < 55 mg/dL," setting the achievement rate of LDL-C < 70 mg/dL (25.4%) as the performance goal for secondary prevention in high-risk patients with coronary artery disease in a published paper using Japanese DPC data.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Achievement rate of LDL-C < 70 mg/dL at 1 year
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Other |
Interventions/Control_1
Lipid management treatment flow with the goal of "an LDL-C reduction of >= 50% from baseline and LDL-C < 55 mg/dL"
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 aged 18 years or older at the time of enrollment
(2) Patients diagnosed with coronary artery disease
(3) Patients diagnosed with hypercholesterolemia (hypercholesterolemia: LDL-C >= 140 mg/dL, or taking cholesterol-lowering medication)
(4) Patients who provide written informed consent to participate in this study
Key exclusion criteria
(1) Patients who are expected to have difficulty visiting the hospital
(2) Patients whose prognosis is expected to be within one year
(3) Patients with statin hypersensitivity, ezetimibe hypersensitivity, or evolocumab hypersensitivity
(4) Patients with the following conditions considered to have impaired liver metabolic function (acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer, jaundice)
(5) Patients who are pregnant, may be pregnant, or wish to become pregnant during treatment
(6) Patients receiving cyclosporine, glecaprevir, or pibrentasvir
(7) Patients with a history of treatment with evolocumab or inclisiran
(8) Patients who have participated in clinical trials of drugs or medical devices at the same time as this study or within 30 days prior to enrollment in this study
(9) Patients who are otherwise deemed inappropriate as subjects by a physician
Target sample size
339
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Hibi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa-ken
TEL
045-787-2800
hibikiyo@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaomi |
| Middle name | |
| Last name | Gohbara |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama, Kanagawa-ken
TEL
045-261-5656
Homepage URL
gocchi3@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University, Ethics Committee for Medical Research Involving Human Subjects
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa-ken
Tel
045-370-7627
rinri@yokohama-cu.ac.jp
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
横浜市立大学附属病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）、済生会横浜市南部病院（神奈川県）、藤沢市民病院（神奈川県）、神奈川県立循環器呼吸器病センター（神奈川県）、横須賀市立うわまち病院［横須賀市立総合医療センター］（神奈川県）、 国立病院機構相模原病院（神奈川県）、国際親善総合病院（神奈川県）、茅ヶ崎市立病院（神奈川県）、大森赤十字病院（東京都）、藤沢湘南台病院（神奈川県） 、JCHO横浜保土ケ谷中央病院（神奈川県）、秦野赤十字病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063807
