NCT04626973Completed
Effects of Ezetimibe Combination Therapy for Patients With Atherosclerotic Cardiovascular Disease; Randomized Comparison of LDL-cholesterol Targeting <70 Versus <55mg/dL; Ez-PAVE Trial
Source: ClinicalTrials.gov · Last updated 17 Nov 2025
Brief summary (registry, in English)
Although the clinical efficacy of LDL-cholesterol lowering therapy has been proven with strong evidences and emphasized, there are also growing concerns that intensive lipid-lowering therapy would be related to increased risk of adverse effects. In addition, statin potency from recent guidelines was set from the studies composed of mainly Caucasian population, although there is an inconsistency of statin effect according to ethnicity. Asian population showed more profound LDL reduction not only from high potent statin but also from moderate to low potent statin. Conventional strategies for lowering LDL-cholesterol focused on statins, therefore doubling of previously described dose of statin would be common way in patients with inadequate LDL-cholesterol levels. Adding ezetimibe will be an alternative strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of high-intensity statin to achieve sufficient LDL-cholesterol lowering effect. However, studies regarding the effect of intensive-targeting of lipid-lowering therapy and therapy regimens are lacking. Thus, on these basis, we sought to evaluate whether intensive-targeting of lipid-lowering therapy will have more prominent beneficial effect compared to conventional-targeting in patients with documented ASCVD with either an ezetimibe/statin combination therapy or a statin monotherapy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 3048 (actual)
- First submitted
- 20 Oct 2020
- Start date
- 15 Jan 2021
- Primary completion date
- 24 Sept 2025
- Lead sponsor
- Yonsei University
- Diseases
- Coronary artery disease
- NCT number
- NCT04626973
What you commit to
- Study type: Interventional
- Participants enrolled: 3048
- From 15 Jan 2021 to the primary completion date, 24 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Solid organ transplantation recipient
Other illness
- Allergy or hypersensitivity to any statin or ezetimibe
Lab values
- LDL-cholesterol level less than 70 mg/dL without statin therapyAllergy or hypersensitive to ezetimibe or statin
- Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
Other
- Pregnant women, women with potential childbearing, or lactating women
- Life expectancy less than 3 years
- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- Inability to understand or read the informed content
Who the study is looking for
- Age 19-80 years
- 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
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
Related publications
- Intensive LDL Cholesterol Targeting in Atherosclerotic Cardiovascular Disease.N Engl J Med · 2026 · PMID 41910315
This page is information, not medical advice. Discuss any trial with your doctor.