Status:
RECRUITING
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
Lead Sponsor:
Saint Vincent's Hospital, Korea
Conditions:
Coronary Artery Disease
Dyslipidemias
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief 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 pa...
Detailed Description
\[Background\]:While high-dose statin is becoming more important, there are factors that limit more widespread use of such a treatment due to the possibility of adverse events, especially among the pa...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
6356 Patients enrolled
Trial Details
Trial ID
NCT06186037
Start Date
February 1 2024
End Date
February 28 2029
Last Update
June 25 2025
Active Locations (1)
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1
St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247