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

9-2022-0119

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

2022-12-01

2025-11-01

2025-11-01

Recruiting

Early phase I

102

Inclusion Criteria: 1. Over 19 years old 2. 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. 3. Patients who underwent percutaneous coronary stenting for acute coronary syndrome Exclusion Criteria: 1. Patients who have previously taken statins, 2. Patients with active liver disease or patients with three times or more increase in AST or ALT 3. If you have an allergic or hypersensitivity reaction to Evorucumab, statin, or Ezetimib, 4. Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study 5. The remaining life expectancy is expected to be less than a year. 6. Subjects who visited the hospital due to psychogenic shock and are expected to be less likely to survive by medical judgment 7. Subjects participating in a randomized clinical trial of medical devices/pharmaceuticals

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 102, 'type': 'ESTIMATED'}}

2024-03-19