Low-Density-Lipoprotein-Type [LDL] HyperlipoproteinemiaPhase 4C-STARNCT05661552
Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI
A Phase 4 study testing Evolocumab 140 MG/ML, Rosuvastatin 5mg and Ezetimibe 10mg in people with Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, run by Yonsei University at 1 site in South Korea.
Trial summary
Investigators aimed to evaluate efficacy and safety of early Initiation of evolocumab and combination lipid-lowering agent (statin + Ezetimibe) on lipid profiles changes in patients with ACS undergoing PCI Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
- What is being tested?
- Evolocumab 140 MG/ML, Rosuvastatin 5mg and Ezetimibe 10mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2022to 5 Feb 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 19 years old
- Patients who agreed to the research protocol and clinical follow-up survey plan, decided to participate in this study voluntarily, and gave written consent to the informed consent form.
- Patients who underwent percutaneous coronary stenting for acute coronary syndrome
Who cannot join
- Patients who have previously taken statins,
- Patients with active liver disease or patients with three times or more increase in AST or ALT
- If you have an allergic or hypersensitivity reaction to Evorucumab, statin, or Ezetimib,
- Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
- The remaining life expectancy is expected to be less than a year.
- Subjects who visited the hospital due to psychogenic shock and are expected to be less likely to survive by medical judgment
- Subjects participating in a randomized clinical trial of medical devices/pharmaceuticals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Initiation of Evolocumab and Combination Lipid-lowering Agent on Lipid Profiles Changes in Patients With Acute Coronary Syndrome Undergoing percuTAneous coronaRy Intervention: a Prospective, Randomized Controlled Trial
Investigators aimed to evaluate efficacy and safety of early Initiation of evolocumab and combination lipid-lowering agent (statin + Ezetimibe) on lipid profiles changes in patients with ACS undergoing PCI
Read the detailed description
Recently, studies have reported that strong LDL cholesterol lowering through PCSK9 inhibitors early in patients with acute myocardial infarction under coronary intervention results in plaque stability as well as plaque regression, which is the cause of arteriosclerosis in the coronary artery. However, the LDL cholesterol reduction effect on statin is different from that of Westerners and Asians, and studies on the LDL cholesterol reduction effect of Koreans on the early use of PCSK9 inhibitors are insufficient. Therefore, we would like to study the effect of reducing LDL cholesterol by administering Evolocumab early after the procedure in patients who underwent percutaneous coronary stent insertion for acute coronary syndrome in the real world.
- Being tested
- Evolocumab 140 MG/ML, Rosuvastatin 5mg, Ezetimibe 10mg
- Keywords
- acute coronary syndrome, low-density-lipoprotein, PCSK9 inhibitor
- 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.
Evolocumab 140 MG/MLDrug
Also called REPATHA® (Amgen Inc, Thousand Oaks, California, USA)
Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe
Rosuvastatin 5mgDrug
Rosuvastatin 5mg will be assigned to all participants
Ezetimibe 10mgDrug
Ezetimibe 10mg will be assigned to all participants
| Study group | Role | What they receive |
|---|---|---|
| Evolocumab treatment group | Experimental | The experimental group will receive Rosuvastatin 5 mg, Ezetimibe 10 mg, and evolocumab by subcutaneous injection. Evolocuumab will be administered at a dose of 140 mg once during the study period. Receives: Drug: Evolocumab 140 MG/ML; Drug: Rosuvastatin 5mg; Drug: Ezetimibe 10mg |
| Group not receiving evolocumab | Active comparator | The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg. Receives: Drug: Rosuvastatin 5mg; Drug: Ezetimibe 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in LDL level (%)
Difference in LDL level change between baseline and 2 weeks later in the test group and control group
Measured: Baseline, 2 weeks later
Secondary outcomes (9)
Percent change in LDL level (%)
Percent change in LDL level 2 weeks and 4 weeks later compared to baseline in the test group and control group
Measured: baseline, 2 weeks later 4 weeks later
Differences in LDL level change (mg/dL)
Differences in LDL level change compared to Baseline between test and control groups
Measured: baseline, 2 weeks later 4 weeks later
Presence or absence of side effects
Presence or absence of side effects (muscle pain, digestive disturbance, test abnormalities) after 2 weeks and 4 weeks of discharge compared to baseline in the test group and control group
Measured: baseline, 2 weeks later 4 weeks later
Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level
Liver function test including Aspartate aminotransferase(AST)/alanine
Measured: baseline, 2 weeks later 4 weeks later
Creatine kinase(CK) (IU/L)
Creatine kinase(CK) (IU/L)
Measured: baseline, 2 weeks later 4 weeks later
C-Reactive Protein(CRP) (mg/L)
C-Reactive Protein(CRP) (mg/L)
Measured: baseline, 2 weeks later 4 weeks later
Lipoprotein(a) (nmol/L)
Lipoprotein(a) (nmol/L)
Measured: baseline, 2 weeks later
HbA1c(%) level
HbA1c level at 4 weeks later compared to baseline in the test group and control group
Measured: baseline, 4 weeks later
Cognitive function analysis
Patients perform self-assessment using a 23-item questionnaire that represents the execution and memory area subscales of all short-lived recognition (ECOG) tools. The cognitive functional analysis scale is evaluated on a 5-point scale, and the lower the score, the better the functional scale.
Measured: 2 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Dec 2022
- Primary completion5 Feb 2025
- Study completion5 Feb 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 Low-Density-Lipoprotein-Type [LDL] HyperlipoproteinemiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental and control groups consist of patients undergoing stenting for acute coronary syndrome and will be randomized to receive early evolocumab along with statin/ezetimibe use or no evolocumab. Rosuvastatin 5 mg and Ezetimibe 10 mg are administered to both the experimental group and the control group.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
- Investigators
- Yongcheol Kim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661552
- Sponsor's protocol ID
- 9-2022-0119
- Acronym
- C-STAR
- Status last verified
- Mar 2025
- First submitted
- 5 Dec 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roh JW, Lee OH, Kim Y, Heo SJ, Im E, Cho DK. Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. Korean Circ J. 2026 Apr;56(4):344-355. doi: 10.4070/kcj.2025.0315. Epub 2026 Jan 6.
PubMed 41560483
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Initiation of Evolocumab and Combination Lipid-lowering Agent on Lipid Profiles Changes in Patients With Acute Coronary Syndrome Undergoing percuTAneous coronaRy Intervention: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05661552
- Acronym / sponsor ID
- C-STAR / 9-2022-0119
- Keywords
- acute coronary syndrome, low-density-lipoprotein, PCSK9 inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Daewoong Pharmaceutical Co. LTD.
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 22 Dec 2022 (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.
Investigators aimed to evaluate efficacy and safety of early Initiation of evolocumab and combination lipid-lowering agent (statin + Ezetimibe) on lipid profiles changes in patients with ACS undergoing PCI
Detailed description
Recently, studies have reported that strong LDL cholesterol lowering through PCSK9 inhibitors early in patients with acute myocardial infarction under coronary intervention results in plaque stability as well as plaque regression, which is the cause of arteriosclerosis in the coronary artery. However, the LDL cholesterol reduction effect on statin is different from that of Westerners and Asians, and studies on the LDL cholesterol reduction effect of Koreans on the early use of PCSK9 inhibitors are insufficient. Therefore, we would like to study the effect of reducing LDL cholesterol by administering Evolocumab early after the procedure in patients who underwent percutaneous coronary stent insertion for acute coronary syndrome in the real world.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental and control groups consist of patients undergoing stenting for acute coronary syndrome and will be randomized to receive early evolocumab along with statin/ezetimibe use or no evolocumab. Rosuvastatin 5 mg and Ezetimibe 10 mg are administered to both the experimental group and the control group.
| Arm | Type | Receives |
|---|---|---|
| Evolocumab treatment group | Experimental | Drug: Evolocumab 140 MG/ML, Drug: Rosuvastatin 5mg, Drug: Ezetimibe 10mgThe experimental group will receive Rosuvastatin 5 mg, Ezetimibe 10 mg, and evolocumab by subcutaneous injection. Evolocuumab will be administered at a dose of 140 mg once during the study period. |
| Group not receiving evolocumab | Active comparator | Drug: Rosuvastatin 5mg, Drug: Ezetimibe 10mgThe control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 19 years old
- Patients who agreed to the research protocol and clinical follow-up survey plan, decided to participate in this study voluntarily, and gave written consent to the informed consent form.
- Patients who underwent percutaneous coronary stenting for acute coronary syndrome
Key exclusion criteria (7 listed)
- Patients who have previously taken statins,
- Patients with active liver disease or patients with three times or more increase in AST or ALT
- If you have an allergic or hypersensitivity reaction to Evorucumab, statin, or Ezetimib,
- Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study
- The remaining life expectancy is expected to be less than a year.
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 |
|---|---|---|
| Evolocumab 140 MG/MLAlso: REPATHA® (Amgen Inc, Thousand Oaks, California, USA)Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe | Drug | Evolocumab treatment group |
| Rosuvastatin 5mgRosuvastatin 5mg will be assigned to all participants | Drug | Evolocumab treatment group, Group not receiving evolocumab |
| Ezetimibe 10mgEzetimibe 10mg will be assigned to all participants | Drug | Evolocumab treatment group, Group not receiving evolocumab |
Primary outcome
Percent change in LDL level (%)
Time frame: Baseline, 2 weeks later
Difference in LDL level change between baseline and 2 weeks later in the test group and control group
9 secondary outcomes
Percent change in LDL level (%)
Time frame: baseline, 2 weeks later 4 weeks later
Differences in LDL level change (mg/dL)
Time frame: baseline, 2 weeks later 4 weeks later
Presence or absence of side effects
Time frame: baseline, 2 weeks later 4 weeks later
Liver function test including Aspartate aminotransferase(AST)/alanine aminotransferase(ALT) (IU/L) level
Time frame: baseline, 2 weeks later 4 weeks later
Creatine kinase(CK) (IU/L)
Time frame: baseline, 2 weeks later 4 weeks later
C-Reactive Protein(CRP) (mg/L)
Time frame: baseline, 2 weeks later 4 weeks later
Lipoprotein(a) (nmol/L)
Time frame: baseline, 2 weeks later
HbA1c(%) level
Time frame: baseline, 4 weeks later
Cognitive function analysis
Time frame: 2 weeks later
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 13 Mar 2025.
- Derived from this study: PubMed 41560483Roh JW, Lee OH, Kim Y, Heo SJ, Im E, Cho DK. Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. Korean Circ J. 2026 Apr;56(4):344-355. doi: 10.4070/kcj.2025.0315. Epub 2026 Jan 6.
- Individual participant dataSharing planned: No
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.
Yongcheol 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 Phase 4 study testing Evolocumab 140 MG/ML, Rosuvastatin 5mg and Ezetimibe 10mg in people with Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia, 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 3 inclusion and 7 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 13 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percent change in LDL level (%) (time frame: Baseline, 2 weeks later). 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 NCT05661552, 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 13 Mar 2025.