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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031136
Receipt No. R000035567
Scientific Title A multicenter, open-label, randomized controlled trial to assess the efficacy and safety of appropriate target values for lipid management in patients who have mild to moderate stenosis lesions with high-risk plaques in coronary arteries
Date of disclosure of the study information 2018/03/01
Last modified on 2019/08/06

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Basic information
Public title A multicenter, open-label, randomized controlled trial to assess the efficacy and safety of appropriate target values for lipid management in patients who have mild to moderate stenosis lesions with high-risk plaques in coronary arteries
Acronym A randomized controlled trial comparing the target values for lipid management in patients who have mild to moderate stenosis lesions with high-risk plaques in coronary arteries
Scientific Title A multicenter, open-label, randomized controlled trial to assess the efficacy and safety of appropriate target values for lipid management in patients who have mild to moderate stenosis lesions with high-risk plaques in coronary arteries
Scientific Title:Acronym A randomized controlled trial comparing the target values for lipid management in patients who have mild to moderate stenosis lesions with high-risk plaques in coronary arteries
Region
Japan

Condition
Condition Conditions having mild to moderate stenosis lesions with high-risk plaques in coronary arteries, but not yet developing ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove whether a strict lipid management according to the secondary prevention criteria for high-risk patients can reduce coronary events or stenosis progression in patients who have mild to moderate stenosis lesions with unstable plaque or severe calcification in coronary arteries detected on coronary artery CT, but have not yet developed ischemic heart disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite endpoint: major cardiovascular events (death from coronary artery disease, nonfatal myocardial infarction, operation of coronary revascularization, stroke) and stenosis progression or new stenosis development
Key secondary outcomes All-cause deaths (deaths from cardiac causes or non-cardiac causes, deaths from an unknown cause), ACS onset (nonfatal myocardial infarction, unstable angina), operation of coronary revascularization, stenosis progression or new stenosis development, calcification exacerbation, stroke (atherothrombotic cerebral infarction, cardiogenic cerebral embolism, cerebral hemorrhage), adverse event (AE)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Control (Group A); target values for LDL-C are 100 ~ < 120 mg/dL for high risk category, 120 ~ < 140 mg/dL for medium risk category, and 140 ~ < 160 mg/dL for low risk category, according to the primary prevention criteria based on the JAS Guidelinefor Prevention of Atherosclerotic Cardiovascular Diseases
Interventions/Control_2 Intervention (Group B); target value for LDL-C is < 70 mg/dL, according to the secondary prevention criteria for high-risk patients based on the JAS Guideline for Prevention of Atherosclerotic Cardiovascular Diseases
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with mild to moderate stenosis lesions with positive remodeling (Remodeling Index [RI] >= 1.1) in the trunk, branches or periphery of coronary arteries with a diameter of 2 mm or more, or with advanced coronary artery calcification (Coronary Artery Calcification Score) [CACS]> 400), detected on coronary artery CT.
2)Aged 20 years or more at the time of consent
3)Provided written consent by their free will
Key exclusion criteria 1)With a significant stenosis of the coronary artery which is an indication for revascularization
2)Having a history of myocardial infarction
3)Having a history of coronary artery revascularization (PCI or CABG)
4)Whose LDL-C value already satisfies the secondary prevention criteria in JAS Guideline for Prevention of Atherosclerotic Cardiovascular Diseases at the time of registration
5)Diagnosed with familial hypercholesterolemia-homozygote
6)With poorly controlled diabetes whose HbA1c value is 10% or more
7)With BMI of less than 17 kg/m2
8)With chronic kidney disease whose eGFR value is 30 mL/min/1.73 m2 or less
9)Having a history of complications suspected to be related to the contrast medium
10)With thyroid disease requiring treatment
11)Confirmed bronchial asthma, multiple myeloma, macroglobulinemia, tetany, or pheochromocytoma
12)Having a history of side effects caused by taking statins
13)In poor compliance with medication due to dementia
14)Judged to be inappropriate for participation in this study by the principal investigator/sub-investigators
Target sample size 740

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Morihiro Matsuda
Organization National Hospital Organization Kure Medical Center
Division name Institute for Clinical Research
Zip code
Address 3-1, Aoyama-cyo, Kure-shi, Hiroshima, 737-0023 Japan
TEL 0823-22-3111
Email morihiro-m@kure-nh.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Morihiro Matsuda
Organization National Hospital Organization Kure Medical Center
Division name Institute for Clinical Research
Zip code
Address 3-1, Aoyama-cyo, Kure-shi, Hiroshima, 737-0023 Japan
TEL 0823-22-3111
Homepage URL
Email morihiro-m@kure-nh.go.jp

Sponsor
Institute National Hospital Organization Kure Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道医療センター(北海道)、函館病院(北海道)、水戸医療センター(茨城県)、埼玉病院(埼玉県)、横浜医療センター(神奈川県)、相模原病院(神奈川県)、金沢医療センター(石川県)、京都医療センター(京都府)、大阪医療センター(大阪府)、岡山医療センター(岡山県)、呉医療センター(広島県)、岩国医療センター(山口県)、神戸医療センター(兵庫県)、
愛媛医療センター(愛媛県)、九州医療センター(福岡県)、熊本医療センター(熊本県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 05 Day
Date of IRB
2017 Year 11 Month 15 Day
Anticipated trial start date
2018 Year 03 Month 20 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 04 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035567

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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