Clinical Comparison of Low-dose Rosuvastatin Plus Ezetimibe Combination Therapy and High-dose Rosuvastatin Monotherapy in Patients With Minimal to Intermediate Coronary Artery Disease Without Percutaneous Coronary Intervention

• Status: Recruiting
• Trial end date: 2029-02-28
• Target enrollment: 0
• Participant gender: All

Summary

[Purpose of the Clinical Study]:The purpose of this study is to conduct a clinical comparison of low-dose rosuvastatin plus ezetimibe combination therapy and high-dose rosuvastatin monotherapy in patients with minimal to intermediate coronary artery disease without percutaneous coronary intervention to confirm non-inferiority in the reduction of key cardiovascular events.

[Hypothesis]:In patients who have not undergone percutaneous coronary intervention for minimal to moderate coronary artery disease, low-dose rosuvastatin and ezetimibe combination therapy are non-inferior in terms of reducing major cardiovascular events compared to high-dose rosuvastatin monotherapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saint Vincent's Hospital, Korea
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Male and female adjusts (19 or older)

2. Patients with suspected stable angina pectoris without coronary artery interventions, who showed a minimal to intermediate coronary artery diseases (a stenosis of 10 to 70% diameter as per QCA) in at least one natural coronary artery in coronary artery angiography or coronary artery CT.

3. Patients who gave their informed consent themselves in writing.

4. Patients who were treated with statin or lipid-lowering agents may participate in the study by changing the existing medicines.

Exclusion Criteria:

1. Patients with an intermediate (>30%) lesion on the left main coronary artery.

2. Patients diagnosed with acute coronary artery diseases (STEMI, NSTEMI, Unstable angina)

3. Patients who received percutaneous coronary intervention

4. Patients who have been diagnosed with stroke, transitory ischemic attack, and peripheral artery diseases.

5. Patients diagnosed with variant angina

6. Patients with severe liver diseases or lung diseases and/or malignant tumor

7. Patients with severe valvular heart disease

8. Patients who are hypersensitive or prohibited from using the active substance (Ezetimibe or Rosuvastatin) of the study medicines

9. Patients whose remaining life expectancy is less than a year

10. Patients with cardiogenic shock

11. Pregnant women or women who are planning to get pregnant

12. Patients who are receiving hemodialysis or peritoneal dialysis or received renal transplantation due to end-stage renal failure

13. Patients who participated in other clinical studies within the past three months (except for non-interventional observation studies)