Effects of Ezetimibe Combination Therapy for Patients With Atherosclerotic Cardiovascular Disease; Randomized Comparison of LDL-cholesterol Targeting <70 Versus <55mg/dL; Ez-PAVE Trial

Launched by YONSEI UNIVERSITY · Nov 8, 2020

Keywords

ClinConnect Summary

The Ez-PAVE Trial is studying how effective a combination therapy of ezetimibe and statins can be for patients with atherosclerotic cardiovascular disease (ASCVD). The goal is to see if targeting lower LDL-cholesterol levels (a type of fat in the blood that can lead to heart problems) at less than 70 mg/dL is as beneficial as going even lower, at less than 55 mg/dL. LDL-cholesterol lowering is important because high levels can increase the risk of heart attacks and strokes. This trial is particularly focused on understanding how these treatments work in different populations, especially among Asian patients who may respond differently to cholesterol-lowering medications.

To be eligible for the trial, participants should be between 19 and 80 years old and have a history of ASCVD, which can include previous heart attacks, unstable angina, strokes, or other related conditions. Participants will receive either the combination therapy of ezetimibe and statins or just statins alone, and they'll be followed closely to monitor their health over the course of the study. It’s important to note that those with certain health conditions, like active liver disease or severe allergies to these medications, won't be able to join. This trial aims to find the best way to manage cholesterol levels safely and effectively for people with heart disease.

Gender

ALL

Eligibility criteria

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