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

  • STATUS
    Recruiting
  • End date
    Sep 21, 2025
  • participants needed
    3048
  • sponsor
    Yonsei University
Updated on 21 June 2021

Summary

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.

Description

All eligible patients who have documented ASCVD will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent. At the time of enrollment, we will stratify all patients according to LDL-cholesterol <100mg/dL, DM, and acute coronary syndrome, and randomly assign them in two groups according to LDL-cholesterol targeting level with a 1:1 ratio: "Intensive-targeting group" vs. "Conventional-targeting group". In addition, patients in each group will be randomly assigned to receive two lipid-lowering therapy regimen with a 1:1 ratio: "Ezetimibe/Statin combination therapy" vs. "Statin monotherapy". Patients allocated to each treatment group will receive lipid-lowering therapy with following protocols.

Details
Condition Atherosclerotic Cardiovascular Disease
Treatment Ezetimibe/Statin Combination therapy, Statin monotherapy
Clinical Study IdentifierNCT04626973
SponsorYonsei University
Last Modified on21 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Allergy or hypersensitivity to any statin or ezetimibe
Solid organ transplantation recipient
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
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