None listed
Conditions
Interventions
Drug : Test subjects who meet the selection/exclusion criteria and agree to participate in the clinical trial will be assigned to the test group (ezetimibe/rosuvastatin 10/5 mg, 10/10 mg, or 10/20 mg)
Sponsors
Inje University Ilsan Paik Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with ischemic stroke, transient ischemic attack, or cerebrovascular artery disease 2. Patients receiving statin monotherapy - Patients receiving concomitant therapy with Omega-3 or fibrate medications are also eligible for enrollment: the same Omega-3 or fibrate medication should be maintained during the clinical trial period. - Patients taking other statins or statin/ezetimibe combination therapy are excluded. 3. Patients with a baseline LDL-C level of 70 mg/dL or higher - The measurement taken during routine clinical visits within the past 3 months will be used as the baseline value. 4. Adult men and women aged 19 years or older 5. Patients who voluntarily provide written consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Subjects who are planning cardiovascular intervention before the completion of this clinical trial 2. Subjects with significant hepatic impairment (ALT or AST levels > 120 IU/L) 3. Subjects with known allergy or contraindication to Rosuvastatin or Ezetimibe 4. Alcohol or drug abusers 5. Pregnant or lactating women 6. Patients with severe anemia: Hb level <10 g/dL for men and <9 g/dL for women 7. Women who cannot use contraception during the study period 8. Subjects with a life expectancy of less than 6 months due to malignancy or other serious health conditions affecting life expectancy 9. Subjects receiving Cyclosporine or protease therapy 10. Patients with severe renal impairment due to end-stage renal disease (creatinine clearance <30mL/min) 11. Subjects who cannot comply with the clinical trial procedures specified in the protocol 12. Subjects who have participated in another clinical trial within the past 3 months 13. Employees of the investigator's institution or research site who are directly involved in the conduct of the study 14. Other individuals who are deemed by the investigator to be unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with LDL-C levels less than 70 mg/dL measured at 90 days (±30 days) after taking the study medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative reduction in LDL-C levels measured at 90 days (±30 days) compared to Baseline. [(Baseline LDL-C - FU LDL-C)/(Baseline LDL-C)]x100 (%);Absolute reduction in LDL-C levels measured at 90 days (±30 days) compared to Baseline: Baseline LDL-C - FU LDL-C (mg/dL);Proportion of patients with LDL-C levels below 55mg/dL at 90 days (±30 days) compared to Baseline.;The proportion of patients who achieved multiple lipid targets. (Total-C < 200 mg/dL, LDL-C < 70 mg/dL, triglyceride < 150 mg/dL);Composite cardiovascular events: Composite cardiovascular events include stroke (ischemic or hemorrhagic), acute coronary syndrome, vascular reconstruction surgery (including coronary arteries, cerebral vessels, peripheral arteries) for atherosclerotic diseases, and death from other vascular diseases.;All-cause mortality;Occurrence of new-onset diabetes | — |
Countries
Korea, Republic of
Contacts
Public ContactKeun-Sik Hong
Inje University Ilsan Paik Hospital
Outcome results
None listed