A Study on the Efficacy and Safety of Early Use of New Cholesterol-lowering Agents (PCSK9 Inhibitors) in Patients after Stent Procedure for Acute Myocardial Infarction

Efficacy and Safety of Early PCSK9 inhibitor Treatment after Percutaneous Coronary Intervention in Acute Myocardial Infarction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011833

Enrollment

Registered

2026-04-10

Start date

2024-11-08

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : This study compares two lipid-lowering strategies in AMI patients undergoing PCI. Intervention Group: Triple therapy consisting of once-daily oral rosuvastatin 5mg/ezetimibe 10mg and subcutane

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female adults aged 19 years or older. Patients diagnosed with acute myocardial infarction (STEMI or NSTEMI) according to the 4th Universal Definition of Myocardial Infarction who underwent percutaneous coronary intervention (PCI). Statin-naïve patients with baseline LDL-C = 150 mg/dL. Women of childbearing potential who agree to mandatory pregnancy testing. Patients who fully understand the study and provide voluntary written informed consent.

Exclusion criteria

Exclusion criteria: Life expectancy less than 1 year due to malignancy or other comorbidities. Severe hepatic impairment (Child-Pugh Class B or C). Known hypersensitivity or contraindications to the study drugs (Rosuvastatin, Ezetimibe, or Evolocumab) or their components. Pregnant or breastfeeding women. End-stage renal disease (ESRD) patients on dialysis (hemodialysis or peritoneal) or kidney transplant recipients. Participation in other interventional clinical trials within 3 months prior to screening (excluding non-interventional observational studies).

Design outcomes

Primary

Measure	Time frame
Change in LDL-cholesterol from baseline to 3 months	—

Secondary

Measure	Time frame
Changes in LDL cholesterol at 4 weeks and 6 months;Composite incidence of Major Adverse Cardiovascular Events (MACE: CV death, MI, and stroke);Changes in liver enzymes (AST/ALT);Total cholesterol at 4 weeks, 3 months, and 6 months from baseline;HDL cholesterol at 4 weeks, 3 months, and 6 months from baseline;Triglyceride at 4 weeks, 3 months, and 6 months from baseline;incidence of new-onset diabetes;statin-associated muscle symptoms (SAMS)	—

Measure

Time frame

Changes in LDL cholesterol at 4 weeks and 6 months;Composite incidence of Major Adverse Cardiovascular Events (MACE: CV death, MI, and stroke);Changes in liver enzymes (AST/ALT);Total cholesterol at 4 weeks, 3 months, and 6 months from baseline;HDL cholesterol at 4 weeks, 3 months, and 6 months from baseline;Triglyceride at 4 weeks, 3 months, and 6 months from baseline;incidence of new-onset diabetes;statin-associated muscle symptoms (SAMS)

—

Countries

Korea, Republic of

Contacts

Public ContactJeen Hwa Lee

Hallym University Medical Center-Dongtan

jeenhwa11@naver.com+82-31-8086-2530

Outcome results