LDL-Cholesterolemia in Stable Coronary Artery Disease
Conditions
Interventions
Intensive LDL-C Lowering:To achieve the LDL-C level under 70mg/dl, increase the dose of statins or change into a strong statin or combine drugs such as ezetimibe with a statin
Standard LDL-C Lowering:
Sponsors
National Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with stable coronary artery disease satisfied with the followings; 1) Serum LDL-Cholesterol level over 100mg/dl 2) Coronary stenosis over 75% (AHA clasification) is confirmed by Coronary angiogram or CT/MRI 3) men and women aged 20-80years 4) patients signed their consent form 5) dosen't matter any previous lipid-lowering therpy
Exclusion criteria
Exclusion criteria: 1) Acute coronary syndrome(Unstable angina,patients who had a myocardial infarction within 2 weeks) 2) abnormal liver function(AST/ALT/ALP> 3 times the upper limit of normal) 3) impaired renal function(creatinine>2 times the upper limit of normal) 4) secondary hypercholesterolemia, drug-induced hypercholesterolemia, and familial hypercholesterolemia 5) patients who cannot quit fibrates 6) Uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110mmHg) 7) Uncontrolled diabetes mellitus (HbA1c over 9.5%) 8) women who are pregnant or give the breaset, or women who have a possibility of pregnancy 9) patients judged as ineligible by doctors in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events (Sudden cardiac death,Lethal or Non-lethal myocardial infarction, Lethal or Non-lethal Stroke,Lethal or Non-lethal Cerebrovascular hemorrhage) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Death, Revascularization(Coronary arteries,Aorta,Peripheral vessels), Heart failure, Unstable angina 2) Lipid Profiles 3) Adverse events | — |
Countries
Japan
Outcome results
None listed