Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)SMARTDECISION2NCT07626840
Livalozet Versus High-intensity Statin in Older Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
A study testing Pitavastatin/ezetimibe and Atorvastatin or Rosuvastatin in people with Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), run by Samsung Medical Center.
Trial summary
Acute myocardial infarction is one of the leading causes of death in elderly patients, and the importance of lipid-lowering therapy as a secondary prevention strategy to reduce cardiovascular events is emphasized. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Pitavastatin/ezetimibe and Atorvastatin or Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 75 years or older
- Patients diagnosed with stable coronary artery disease or acute coronary syndrome and requiring coronary artery intervention due to coronary artery stenosis
- Patients with primary hypercholesterolemia and mixed dyslipidemia
- Patients who understand the risks and benefits of treatment, as well as alternatives, and can voluntarily sign the informed consent form
Who cannot join
- Patients with hypersensitivity or contraindications to statins or ezetimibe
- Patients with active liver disease or persistently elevated AST or ALT levels exceeding three times the upper limit of normal
- Patients with a history of organ transplantation (kidney, liver, etc.)
- Pregnant or lactating women
- Patients with a life expectancy of less than one year due to non-cardiac disease, or those deemed unable to participate in the study and follow-up (based on the medical judgment of the investigator at each site)
About this study
Official title: Pitavastatin With Ezetimibe Combination Therapy Versus High-intensity Statin in Older Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Acute myocardial infarction is one of the leading causes of death in elderly patients, and the importance of lipid-lowering therapy as a secondary prevention strategy to reduce cardiovascular events is emphasized. The European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines recommend lowering low-density lipoprotein-cholesterol (LDL-C) below 55 mg/dL or by at least 50% from baseline as a treatment goal and recommend high-intensity statin therapy (Atorvastatin 40-80 mg, Rosuvastatin 20 mg). Statins have been shown to reduce cardiovascular risk in elderly patients as well. However, these patients exhibit a higher rate of statin intolerance due to side effects associated with high-intensity statins, such as myalgia, hepatotoxicity, cognitive decline, and increased risk of diabetes. Consequently, dose reduction or discontinuation is required more frequently compared to younger patients. Therefore, establishing an appropriate lipid-lowering strategy for elderly patients is necessary, considering not only efficacy but also drug tolerability. Consequently, in elderly patients, reducing the statin intensity from the outset and considering combination therapy with drugs having different mechanisms of action, such as ezetimibe, may be warranted. Pitavastatin is classified as a moderate-intensity statin. Previous studies have confirmed that Pitavastatin demonstrates non-inferior efficacy compared to Rosuvastatin and Atorvastatin. Several observational studies report that Pitavastatin has fewer drug interactions than other statins and lower rates of diabetes onset and elevated liver enzymes. Therefore, Pitavastatin may be an appropriate choice for moderate-intensity statin therapy in elderly patients. Thus, this study aims to evaluate whether combination therapy with Pitavastatin and Ezetimibe (Livalozet 4/10mg) after coronary intervention in patients aged 75 years or older with coronary artery disease is non-inferior to high-intensity statin therapy (Atorvastatin 40-80 mg or Rosuvastatin 20 mg). If this study demonstrates that moderate-intensity statin therapy combined with ezetimibe is non-inferior to high-intensity statin therapy while also having fewer adverse effects, it could provide evidence for an effective and safe cholesterol treatment option for elderly patients.
- Being tested
- Pitavastatin/ezetimibe, Atorvastatin or Rosuvastatin
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitavastatin/ezetimibeDrug
Also called Livalozet 4/10mg
Livalozet 4/10mg will be administered once daily orally according to the study protocol.
Atorvastatin or RosuvastatinDrug
Also called rosuvastatin, atorvastatin
Atorvastatin 40 mg, 80 mg or Rosuvastatin 20 mg once daily orally as determined by the physician.
| Study group | Role | What they receive |
|---|---|---|
| pitavastatin/ezetimibe combination therapy group | Experimental | Livalozet 4/10mg once daily orally, continue until follow-up is complete. Receives: Drug: Pitavastatin/ezetimibe |
| high-intensity statin monotherapy group | Active comparator | Atorvastatin 40 mg, 80 mg or Rosuvastatin 20 mg once daily orally, continue until follow-up is complete. Receives: Drug: Atorvastatin or Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
A composite of cardiovascular death, MI, stroke, and unplanned revascularization
Measured: 2 year
Secondary outcomes (1)
Major Adverse Cardiovascular Events (MACE)
A composite of cardiovascular death, MI, stroke, and unplanned revascularization
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo-Yong Hahn, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626840
- Sponsor's protocol ID
- SMC2025-11-105
- Acronym
- SMARTDECISION2
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pitavastatin With Ezetimibe Combination Therapy Versus High-intensity Statin in Older Patients With Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07626840
- Acronym / sponsor ID
- SMARTDECISION2 / SMC2025-11-105
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 4 Jun 2026 (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.
Acute myocardial infarction is one of the leading causes of death in elderly patients, and the importance of lipid-lowering therapy as a secondary prevention strategy to reduce cardiovascular events is emphasized. The European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines recommend lowering low-density lipoprotein-cholesterol (LDL-C) below 55 mg/dL or by at least 50% from baseline as a treatment goal and recommend high-intensity statin therapy (Atorvastatin 40-80 mg, Rosuvastatin 20 mg). Statins have been shown to reduce cardiovascular risk in elderly patients as well. However, these patients exhibit a higher rate of statin intolerance due to side effects associated with high-intensity statins, such as myalgia, hepatotoxicity, cognitive decline, and increased risk of diabetes. Consequently, dose reduction or discontinuation is required more frequently compared to younger patients. Therefore, establishing an appropriate lipid-lowering strategy for elderly patients is necessary, considering not only efficacy but also drug tolerability. Consequently, in elderly patients, reducing the statin intensity from the outset and considering combination therapy with drugs having different mechanisms of action, such as ezetimibe, may be warranted. Pitavastatin is classified as a moderate-intensity statin. Previous studies have confirmed that Pitavastatin demonstrates non-inferior efficacy compared to Rosuvastatin and Atorvastatin. Several observational studies report that Pitavastatin has fewer drug interactions than other statins and lower rates of diabetes onset and elevated liver enzymes. Therefore, Pitavastatin may be an appropriate choice for moderate-intensity statin therapy in elderly patients. Thus, this study aims to evaluate whether combination therapy with Pitavastatin and Ezetimibe (Livalozet 4/10mg) after coronary intervention in patients aged 75 years or older with coronary artery disease is non-inferior to high-intensity statin therapy (Atorvastatin 40-80 mg or Rosuvastatin 20 mg). If this study demonstrates that moderate-intensity statin therapy combined with ezetimibe is non-inferior to high-intensity statin therapy while also having fewer adverse effects, it could provide evidence for an effective and safe cholesterol treatment option for elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pitavastatin/ezetimibe combination therapy group | Experimental | Drug: Pitavastatin/ezetimibeLivalozet 4/10mg once daily orally, continue until follow-up is complete. |
| high-intensity statin monotherapy group | Active comparator | Drug: Atorvastatin or RosuvastatinAtorvastatin 40 mg, 80 mg or Rosuvastatin 20 mg once daily orally, continue until follow-up is complete. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 75 years or older
- Patients diagnosed with stable coronary artery disease or acute coronary syndrome and requiring coronary artery intervention due to coronary artery stenosis
- Patients with primary hypercholesterolemia and mixed dyslipidemia
- Patients who understand the risks and benefits of treatment, as well as alternatives, and can voluntarily sign the informed consent form
Key exclusion criteria (5 listed)
- Patients with hypersensitivity or contraindications to statins or ezetimibe
- Patients with active liver disease or persistently elevated AST or ALT levels exceeding three times the upper limit of normal
- Patients with a history of organ transplantation (kidney, liver, etc.)
- Pregnant or lactating women
- Patients with a life expectancy of less than one year due to non-cardiac disease, or those deemed unable to participate in the study and follow-up (based on the medical judgment of the investigator at each site)
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 |
|---|---|---|
| Pitavastatin/ezetimibeAlso: Livalozet 4/10mgLivalozet 4/10mg will be administered once daily orally according to the study protocol. | Drug | pitavastatin/ezetimibe combination therapy group |
| Atorvastatin or RosuvastatinAlso: rosuvastatin, atorvastatinAtorvastatin 40 mg, 80 mg or Rosuvastatin 20 mg once daily orally as determined by the physician. | Drug | high-intensity statin monotherapy group |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 2 year
A composite of cardiovascular death, MI, stroke, and unplanned revascularization
1 secondary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pitavastatin/ezetimibe and Atorvastatin or Rosuvastatin in people with Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), run by Samsung Medical Center.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Major Adverse Cardiovascular Events (MACE) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.