None listed
Conditions
Interventions
None listed
Sponsors
Chonnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults = 18 years old 2. Very high risk of future atherosclerotic cardiovascular disease (ASCVD) Events : Multiple major ASCVD events or 1 major ASCVD event and multiple high-risk conditions 3. Receiving current optimal (maximal or maximal tolerated) statin therapy for at least 3 months prior to patient enrollment 4. LDL-C = 1.8 mmol/L (70mg/dL) measured within 6 months of patient enrollment date and while on (despite) maximal tolerated statin therapy (± other lipid modifying therapies including ezetimibe). 5. Desire and ability to execute the consent to participate. * Major ASCVD Events - Recent acute coronary syndromes (ACS) (within the past 12 months) - History of myocardial infarction (other than recent ACS event listed above) - History of ischemic stroke - Symptomatic peripheral arterial disease (history of claudication with ABI >0.85, or previous revascularization or amputation) * High-Risk Conditions - Age = 65 y - Heterozygous familial hypercholesterolemia - History of prior coronary artery bypass surgery or percutaneous coronary intervention outside of the major ASCVD event(s) - Diabetes mellitus - Hypertension - CKD (eGFR 15-59 mL/min/1.73 m2) - Current smoking - Persistently elevated LDL-C (LDL-C = 100mg/dL[=2.6 mmol/L]) despite maxillary tolerated statin therapy and ezetimibe - History of congestive HF
Exclusion criteria
Exclusion criteria: 1. Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study 2. Severe, concomittent non-cardiovascular disease with a life expectancy shorter than 1 year 3. Severe renal or liver dysfunction 4. Untreated or inadequately treated hyperthyroidism or hypothyroidism 5. Homozygous familial hypercholesterolemia 6. Participation in an investigational study 7. Participation in an other study that can affect the level of lipid profile
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving LDL-C < 1.8mmol/L at 0week, 6-16weeks, 18-30weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients in each type of medication insurance coverage;Proportion of patients receiving either ezetimibe or PCSK9 inhibitor as add on lipid lowering therapy;Proportion of patients not receiving either ezetimibe or PCSK9 inhibitor mainly due to cost consideration/ reimbursement limitations;Proportion of patients not receiving either ezetimibe or PCSK9 inhibitor mainly due to medical constraints such as comorbidities;Proportion of patients not receiving either ezetimibe or PCSK9 inhibitor mainly due to physician's disagreement with the guidelines;Proportion of patients not receiving either ezetimibe or PCSK9 inhibitor mainly due to patient's disagreement (other than cost/ reimbursement limitations) | — |
Countries
Korea, Republic of
Contacts
Public ContactKyung Hoon Cho
Chonnam National University Hospital
Outcome results
None listed