Effects of ezetimibe combination therapy for patients with atherosclerotic cardiovascular disease; randomized comparison of LDL-cholesterol targeting <70 versus <55mg/dL; Ez-PAVE trial

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0005547

Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 3048

Inclusion Criteria

1. Age 19-80 years
2. Documented atherosclerotic cardiovascular disease (ASCVD)
A. Previous acute coronary syndrome (myocardial infarction [MI] or unstable angina),
B. Or stable angina with imaging or functional studies
C. Or coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG], and other arterial revascularization procedures)
D. Or stroke and transient ischemic attack (TIA)
E. Or peripheral artery disease.

Exclusion Criteria

1. LDL-cholesterol level less than 70 mg/dL without statin therapyAllergy or hypersensitive to ezetimibe or statin
2. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
3. Allergy or hypersensitivity to any statin or ezetimibe
4. Solid organ transplantation recipient
5. Pregnant women, women with potential childbearing, or lactating women
6. Life expectancy less than 3 years
7. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
8. Inability to understand or read the informed content

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical outcomes (Composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, any revascularization, and hospitalization for angina)

Secondary Outcome Measures

Name	Time	Method
Each component of primary endpoint within 3 years (Composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, any revascularization, and hospitalization for angina);Various composite outcomes within 3 years: A. Composite of cardiovascular death, non-fatal MI, and non-fatal stroke, B. Composite of cardiovascular death, non-fatal MI, non-fatal stroke, and any revascularization, C. Composite of cardiovascular death, non-fatal MI, and any revascularization, D. Composite of all-cause death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for angina;Proportion of subjects achieving target LDL-cholesterol level;Rate of cross-over into the non-allocated therapy regimen in order to achieve target LDL-cholesterol level;Proportions of subjects requiring proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to achieve target LDL-cholesterol level;Difference in clinical endpoints according to various anthropomorphic characteristics