Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients

Inclusion Criteria:

1. Patients who are ≥ 30 years old.

2. Patients with very high-risk*: clinical or unequivocal on imaging ASCVD. ASCVDincludes previous ACS (MI or UA), stable angina, coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), and other arterial revascularization procedures), stroke and transientischaemic attack (TIA), and peripheral arterial disease (Mach F 2020).

3. Patients (a) who failed to achieve their target LDL-C goals with low and/or moderateintensity statin mono therapy for ≥ 4 weeks or (b) who are statin-naïve or have notbeen on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment

• rosuvastatin < 10 mg, atorvastatin < 40 mg, and all dose of pitavastatin,simvastatin, lovastatin, pravastatin, and fluvastatin (Team G 2020).

4. Patients with LDL-C levels ≥ 70 mg/dL

5. Patients who are willing to maintain TLC throughout the study.

6. Patients who are willing to provide written informed consent prior to studyenrollment.

Exclusion Criteria:

1. Patients with hypersensitivity to ezetimibe, atorvastatin or any of its inactiveingredients.

2. Patients with active liver disease or unexplained persistent elevations of hepatictransaminase levels. (aspartate transaminase (AST) or alanine transaminase (ALT) > 3x upper limit of normal (ULN)).

3. Patients who have predisposing conditions with muscle disease (i.e., rhabdomyolysisor myopathy) or neuromuscular disease.

4. Patients with myasthenia gravis.

5. Female patients who are pregnant or have a potential to be pregnant and nursing.

6. Patients who are taking glecaprevir and pibrentasvir.

7. Patients with hereditary problems of galactose intolerance, lapp lactase deficiency,or of glucose-galactose malabsorption.

8. Patients with disease known to influence serum lipids or lipoproteins excludingdyslipidemia.

9. Patients with a history of cancer within 5 years.

10. Patients whose life expectancy is less than 6 months due to their medicalconditions.

11. Patients with any condition or situation that might pose a risk to the participantor interfere with participation in the study.

12. Patients who have received any investigational medicine within 12 weeks of writteninformed consent or are going to receive during the clinical trial period.

13. Patients who are judged to be difficult to conduct clinical trials according to thejudgment of the investigator.