This is a phase 4, multicenter, randomized, open-label, active-controlled study to evaluate the effectiveness and safety of early add-on of ezetimibe with atorvastatin in very high-risk patients.~In Visit 1, screening is conducted for patients in the very high-risk group. LDL-C needs to be above 70 mg/dL in patients (a) who failed to achieve their target LDL-C goals with mild to moderate intensity statin; (b) who are statin-naive or have not been on a stable statin regimen for at least 4 weeks prior to enrollment. However, by tracking the registration status of patients, (b) patients should be enrolled not to exceed 40% of each group. All laboratory tests are performed in the local laboratory and the Visit 1 results may be substituted if available within 2 weeks prior to the screening visit. The study participation is determined through the inclusion/exclusion criteria based on the test results conducted for Visit 1. In the case of the lipid parameter, Visit 1 results are used as the baseline. Individuals who do not meet the criteria for participation in this study (screen failure) may be rescreened once.~In Visit 2, randomization is performed on patients who meet the inclusion criteria and do not meet any of the exclusion criteria and will be distributed 1:1 between test group (arm Eze/Ato) and control group (arm Ato). The results of laboratory tests at the Visit 2 are used as baseline except lipid parameters. Visit 1 and Visit 2 may be conducted on the same date.~In Visit 2 and Visit 3, the appropriate investigational medical product (IMP) is given to each group. In principle, IMPs are administered orally once a day from the day of distribution.~For participants whose LDL-C value has reached the target (LDL-C < 55 mg/dL) according to the lipid indicator test at Visit 3, they will continue treatment with the same dose for 6 weeks. If the LDL-C level has not reached target, the dose of atorvastatin should be increased to ezetimibe/atorvastatin 10/80 mg or atorvastatin 80 mg according to the group assigned. In principle, a morning visit is recommended so that the laboratory test results can be checked and the IMP can be prescribed and taken on the same day. However, if the test results are not confirmed on the same day, the investigator continues to prescribe the same dose of IMP(ezetimibe/atorvastatin 10/40 mg or atorvastatin 40 mg) the participant was taking for one more week, and an additional visit is made within 1 week to receive the new IMP. Visit 4 is the end of study visit, and tests for effectiveness and safety are conducted.~63 patients for each group and thus, a total of 126 patients will be randomized in this study.
This study aims to confirm the effectiveness of ezetimibe add-on therapy on LDL-C levels compared to atorvastatin monotherapy, especially in very high-risk patients. We intend to lay the foundation for a standard treatment for these patients through ezetimibe add on lipid-lowering therapy.