Atherosclerotic Cardiovascular DiseaseNCT04626973
Effects of Ezetimibe Combination Therapy for Patients With Atherosclerotic Cardiovascular Disease; Randomized Comparison of LDL-cholesterol Targeting <70 Versus <55mg/dL; Ez-PAVE Trial
A study testing Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin) and Statin monotherapy (rosuvastatin or atorvastatin) in people with Atherosclerotic Cardiovascular Disease, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin) and Statin monotherapy (rosuvastatin or atorvastatin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,048 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2021to 24 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul
About this study
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.
Read the detailed 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.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin), Statin monotherapy (rosuvastatin or atorvastatin)
- Keywords
- Dyslipidemia, ASCVD, Coronary artery disease
- Medical subject headings
- Atherosclerosis, Dyslipidemias, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin)Drug
For statin naive patients, patients would initially receive Ezetimibe 10mg plus Rosuvastatin 10 or 20 mg.
For non-statin naive patients, regimens are to be changed to the equivalent dose of ezetimibe+rosuvastatin combination in case of already achieved LDL-cholesterol target (<55 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target.
Statin monotherapy (rosuvastatin or atorvastatin)Drug
For statin naive patients, patients would initially receive Rosuvastatin 20mg or Atorvastatin 40 or 80 mg.
For non-statin native patients, regimens are to be change to equivalent dose of atorvastatin or rosuvastatin in case of already achieved LDL-cholesterol target (<55 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target.
Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin)Drug
For statin naive patients, patients would initially receive Ezetimibe 10mg plus Rosuvastatin 5 or 10mg.
For non-statin naive patients, regimens are to be changed to the equivalent dose of ezetimibe+rosuvastatin combination in case of already achieved LDL-cholesterol target (<70 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target.
Statin monotherapy (rosuvastatin or atorvastatin)Drug
For statin naive patients, patients would initially receive Rosuvastatin 10 or 20mg or Atorvastatin 20 or 40mg. For non-statin native patients, regimens are to be change to equivalent dose of atorvastatin or rosuvastatin in case of already achieved LDL-cholesterol target (<70 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target.
| Study group | Role | What they receive |
|---|---|---|
| Intensive-targeting group | Experimental | Not described Receives: Drug: Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin); Drug: Statin monotherapy (rosuvastatin or atorvastatin) |
| Conventional-targeting group | Active comparator | Not described Receives: Drug: Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin); Drug: Statin monotherapy (rosuvastatin or atorvastatin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes by different lipid-lowering therapy
Composite of cardiovascular death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for unstable angina
Measured: Within 3 years after the enrollment
Secondary outcomes (16)
Each component of primary endpoint within 3 years
- A. Rate of Cardiovascular death
- B. Rate of non-fatal MI
- C. Rate of non-fatal stroke
- D. Rate of any revascularization
- E. Rate of hospitalization for unstable angina
Measured: Within 3 years after the enrollment
Various composite outcomes within 3 years
- A. Rate of composite of cardiovascular death, non-fatal MI, and non-fatal stroke
- B. Rate of composite of cardiovascular death, non-fatal MI, non-fatal stroke, and any revascularization
- C. Rate pf composite of cardiovascular death, non-fatal MI, and any revascularization
- D. Rate of composite of all-cause death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for unstable angina
Measured: Within 3 years after the enrollment
Proportion of subjects achieving target LDL-cholesterol level
Measured: Within 3 years after the enrollment
Rate of cross-over into the non-allocated therapy regimen in order to achieve target LDL-cholesterol level
Measured: Within 3 years after the enrollment
Proportions of subjects requiring proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to achieve target LDL-cholesterol level
Measured: Within 3 years after the enrollment
Difference in rate of primary outcome according to sex
Measured: Within 3 years after the enrollment
Difference in rate of primary outcome according to body mass index
Measured: Within 3 years after the enrollment
Rate of New-onset diabetes mellitus
Measured: Within 3 years after the enrollment
Rate of worsening of glycemic control or homeostatic model assessment (HOMA)-index
Measured: Within 3 years after the enrollment
Occurrence of statin-associated muscle symptoms (SAMS) requiring change of therapy regimen or dosage
Measured: Within 3 years after the enrollment
Occurence of elevation of muscle enzymes (CPK > 4 x UNL)
Measured: Within 3 years after the enrollment
Occurence of elevation of hepatic enzymes (AST, ALT, or both ≥ 3 x UNL)
Measured: Within 3 years after the enrollment
Occurence of elevation of serum creatinine level (>50% from baseline)
Measured: Within 3 years after the enrollment
Change of proteinuria
Measured: Within 3 years after the enrollment
Rate of cancer diagnosis
Measured: Within 3 years after the enrollment
Rate of operation due to cataract
Measured: Within 3 years after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start15 Jan 2021
- Primary completion24 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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".
- Masking
- None (open label)
- Enrolment
- 3,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Byeong-Keuk Kim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626973
- Sponsor's protocol ID
- 4-2020-0903
- Status last verified
- Nov 2025
- First submitted
- 20 Oct 2020
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee YJ, Lee SJ, Kim JW, Lee SH, Kim GS, Park JH, Cho JM, Kang WC, Yoon HJ, Kim WH, Lee SJ, Lee JB, Jang JY, Shin S, Park IH, Kwon SU, Kim S, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK; Ez-PAVE Investigators. Intensive LDL Cholesterol Targeting in Atherosclerotic Cardiovascular Disease. N Engl J Med. 2026 Apr 9;394(14):1365-1375. doi: 10.1056/NEJMoa2600283. Epub 2026 Mar 28.
PubMed 41910315
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ezetimibe Combination Therapy for Patients With Atherosclerotic Cardiovascular Disease; Randomized Comparison of LDL-cholesterol Targeting <70 Versus <55mg/dL; Ez-PAVE Trial
- ClinicalTrials.gov ID
- NCT04626973
- Acronym / sponsor ID
- 4-2020-0903
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- Dyslipidemia, ASCVD, Coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,048 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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".
| Arm | Type | Receives |
|---|---|---|
| Intensive-targeting group | Experimental | Drug: Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin), Drug: Statin monotherapy (rosuvastatin or atorvastatin) |
| Conventional-targeting group | Active comparator | Drug: Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin), Drug: Statin monotherapy (rosuvastatin or atorvastatin) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 19-80 years
- Documented atherosclerotic cardiovascular disease (ASCVD)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin)For statin naive patients, patients would initially receive Ezetimibe 10mg plus Rosuvastatin 10 or 20 mg. For non-statin naive patients, regimens are to be changed to the equivalent dose of ezetimibe+rosuvastatin combination in case of already achieved LDL-cholesterol target (<55 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target. | Drug | Intensive-targeting group |
| Statin monotherapy (rosuvastatin or atorvastatin)For statin naive patients, patients would initially receive Rosuvastatin 20mg or Atorvastatin 40 or 80 mg. For non-statin native patients, regimens are to be change to equivalent dose of atorvastatin or rosuvastatin in case of already achieved LDL-cholesterol target (<55 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target. | Drug | Intensive-targeting group |
| Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin)For statin naive patients, patients would initially receive Ezetimibe 10mg plus Rosuvastatin 5 or 10mg. For non-statin naive patients, regimens are to be changed to the equivalent dose of ezetimibe+rosuvastatin combination in case of already achieved LDL-cholesterol target (<70 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target. | Drug | Conventional-targeting group |
| Statin monotherapy (rosuvastatin or atorvastatin)For statin naive patients, patients would initially receive Rosuvastatin 10 or 20mg or Atorvastatin 20 or 40mg. For non-statin native patients, regimens are to be change to equivalent dose of atorvastatin or rosuvastatin in case of already achieved LDL-cholesterol target (<70 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target. | Drug | Conventional-targeting group |
Primary outcome
Clinical outcomes by different lipid-lowering therapy
Time frame: Within 3 years after the enrollment
Composite of cardiovascular death, non-fatal MI, non-fatal stroke, any revascularization, and hospitalization for unstable angina
16 secondary outcomes
Each component of primary endpoint within 3 years
Time frame: Within 3 years after the enrollment
Various composite outcomes within 3 years
Time frame: Within 3 years after the enrollment
Proportion of subjects achieving target LDL-cholesterol level
Time frame: Within 3 years after the enrollment
Rate of cross-over into the non-allocated therapy regimen in order to achieve target LDL-cholesterol level
Time frame: Within 3 years after the enrollment
Proportions of subjects requiring proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to achieve target LDL-cholesterol level
Time frame: Within 3 years after the enrollment
Difference in rate of primary outcome according to sex
Time frame: Within 3 years after the enrollment
Difference in rate of primary outcome according to body mass index
Time frame: Within 3 years after the enrollment
Rate of New-onset diabetes mellitus
Time frame: Within 3 years after the enrollment
Rate of worsening of glycemic control or homeostatic model assessment (HOMA)-index
Time frame: Within 3 years after the enrollment
Occurrence of statin-associated muscle symptoms (SAMS) requiring change of therapy regimen or dosage
Time frame: Within 3 years after the enrollment
Occurence of elevation of muscle enzymes (CPK > 4 x UNL)
Time frame: Within 3 years after the enrollment
Occurence of elevation of hepatic enzymes (AST, ALT, or both ≥ 3 x UNL)
Time frame: Within 3 years after the enrollment
Occurence of elevation of serum creatinine level (>50% from baseline)
Time frame: Within 3 years after the enrollment
Change of proteinuria
Time frame: Within 3 years after the enrollment
Rate of cancer diagnosis
Time frame: Within 3 years after the enrollment
Rate of operation due to cataract
Time frame: Within 3 years after the enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Derived from this study: PubMed 41910315Lee YJ, Lee SJ, Kim JW, Lee SH, Kim GS, Park JH, Cho JM, Kang WC, Yoon HJ, Kim WH, Lee SJ, Lee JB, Jang JY, Shin S, Park IH, Kwon SU, Kim S, Hong SJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y, Kim BK; Ez-PAVE Investigators. Intensive LDL Cholesterol Targeting in Atherosclerotic Cardiovascular Disease. N Engl J Med. 2026 Apr 9;394(14):1365-1375. doi: 10.1056/NEJMoa2600283. Epub 2026 Mar 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byeong-Keuk Kim, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin) and Statin monotherapy (rosuvastatin or atorvastatin) in people with Atherosclerotic Cardiovascular Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes by different lipid-lowering therapy (time frame: Within 3 years after the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04626973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.