Conditions having mild to moderate stenosis lesions with high-risk plaques in coronary arteries, but not yet developing ischemic heart disease
Conditions
Interventions
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
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
Sponsors
National Hospital Organization Kure Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactMorihiro Matsuda
National Hospital Organization Kure Medical Center Institute for Clinical Research
Outcome results
None listed