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
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 : A Prospective, Multicenter, Randomized, Open-label Trial
Saint Vincent's Hospital, Korea
6,356 participants
Feb 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Male and female adjusts (19 or older)
- 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.
- Patients who gave their informed consent themselves in writing.
- Patients who were treated with statin or lipid-lowering agents may participate in the study by changing the existing medicines.
Exclusion Criteria12
- Patients with an intermediate (>30%) lesion on the left main coronary artery.
- Patients diagnosed with acute coronary artery diseases (STEMI, NSTEMI, Unstable angina)
- Patients who received percutaneous coronary intervention
- Patients who have been diagnosed with stroke, transitory ischemic attack, and peripheral artery diseases.
- Patients diagnosed with variant myocardial infarction
- Patients with severe liver diseases or lung diseases and/or malignant tumor with life expectancy of less than 3 years
- Patients with severe valvular heart disease
- Patients who are hypersensitive or prohibited from using the active substance (Ezetimibe or Rosuvastatin) of the study medicines
- Patients with cardiogenic shock
- Pregnant women or women who are planning to get pregnant
- Patients who are receiving hemodialysis or peritoneal dialysis or received renal transplantation due to end-stage renal failure
- Patients who participated in other clinical studies within the past three months (except for non-interventional observation studies)
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Interventions
Oral administration once a day, taking it for 3 years
Oral administration once a day, taking it for 3 years
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06186037