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| Name | Class |
|---|---|
| Daewoong Pharmaceutical Co. LTD. | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Group not receiving evolocumab | Active Comparator | The control group receives Rosuvastatin 5 mg and Ezetimibe 10 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evolocumab 140 MG/ML | Drug | Randomly assigned Evolocumab + rosuvastatin + ezetimibe versus rosuvastatin + ezetimibe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in LDL level (%) | Difference in LDL level change between baseline and 2 weeks later in the test group and control group | Baseline, 2 weeks later |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 2 weeks later 4 weeks later |
| Differences in LDL level change (mg/dL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongcheol Kim, MD, PhD | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongcheol Kim | Yongin | Gyeonggi-do | 16995 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41560483 | Derived | 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. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C577155 | evolocumab |
| D000068718 | Rosuvastatin Calcium |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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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.
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| Rosuvastatin 5mg | Drug | Rosuvastatin 5mg will be assigned to all participants |
|
| Ezetimibe 10mg | Drug | Ezetimibe 10mg will be assigned to all participants |
|
Differences in LDL level change compared to Baseline between test and control groups
| 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 | 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 | baseline, 2 weeks later 4 weeks later |
| Creatine kinase(CK) (IU/L) | Creatine kinase(CK) (IU/L) | baseline, 2 weeks later 4 weeks later |
| C-Reactive Protein(CRP) (mg/L) | C-Reactive Protein(CRP) (mg/L) | baseline, 2 weeks later 4 weeks later |
| Lipoprotein(a) (nmol/L) | Lipoprotein(a) (nmol/L) | baseline, 2 weeks later |
| HbA1c(%) level | HbA1c level at 4 weeks later compared to baseline in the test group and control group | 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. | 2 weeks later |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001384 | Azetidines |
| D001385 | Azetines |