Comparing Ezetimibe and Statin Therapy for Heart Disease Patients
Effects of Ezetimibe Combination Therapy for Patients With Atherosclerotic Cardiovascular Disease; Randomized Comparison of LDL-cholesterol Targeting <70 Versus <55mg/dL; Ez-PAVE Trial
This study is testing whether combining ezetimibe with statins can lower cholesterol better than just using statins alone in people with heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3048 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04626973 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of combining ezetimibe with statins versus using statins alone in patients with atherosclerotic cardiovascular disease (ASCVD). Participants will be randomly assigned to either an intensive LDL-cholesterol targeting group or a conventional targeting group, with further randomization into two treatment regimens: ezetimibe/statin combination therapy or statin monotherapy. The study aims to evaluate the efficacy and safety of these treatment strategies in lowering LDL-cholesterol levels while minimizing the risk of adverse effects. The trial will enroll patients aged 19-80 years with documented ASCVD and will follow strict inclusion and exclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19-80 with documented atherosclerotic cardiovascular disease.
Not a fit: Patients with LDL-cholesterol levels below 70 mg/dL or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective approach to managing cholesterol levels in patients with heart disease.
How similar studies have performed: Other studies have shown promising results with similar lipid-lowering strategies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Byeong-Keuk Kim, MD, PhD — Severance Hospital
- Study coordinator: Byeong-Keuk Kim, MD, PhD
- Email: KIMBK@yuhs.ac
- Phone: 82-2-2228-8465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.