Actively Recruiting
Comparison of Low-dose Rosuvastatin Plus Ezetimibe and High-dose Rosuvastatin in Patients With Minimal to Intermediate Coronary Artery Disease Without Intervention
Led by Saint Vincent's Hospital, Korea · Updated on 2025-06-25
6356
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two cholesterol-lowering treatments in patients with minimal to intermediate coronary artery disease who have not had percutaneous coronary intervention. The study aims to see if a combination of low-dose rosuvastatin and ezetimibe is not worse than high-dose rosuvastatin alone in reducing major heart-related events. This is important because high-dose statins can cause side effects, especially in East Asian patients, and the combination might reduce these risks while still lowering LDL cholesterol effectively. The study will include 6,356 patients randomly assigned to one of two groups: one group will take ezetimibe 10 mg combined with rosuvastatin 5 mg once daily, and the other will take rosuvastatin 20 mg once daily. Both treatments will be taken for three years. Follow-up visits to monitor progress will happen at 6 weeks, 6 months, 12 months, and 36 months after starting treatment. Follow-up can be done in person or by phone. Participants will have their health assessed at these visits to monitor for important events such as death, heart attacks, strokes, hospitalizations due to unstable angina, and procedures to improve blood flow to the heart. Researchers will track these combined outcomes over 36 months. Safety and treatment effects will be carefully observed throughout the study period, which runs until 2029.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Patients with minimal to intermediate coronary artery disease showing 10 to 70% narrowing in at least one natural coronary artery
- Patients who have not undergone percutaneous coronary intervention
- Patients who provide written informed consent
- Patients currently treated with statins or lipid-lowering agents may participate after changing existing medicines
You will not qualify if you...
- Patients with more than 30% narrowing in the left main coronary artery
- Patients with acute coronary artery diseases such as STEMI, NSTEMI, or unstable angina
- Patients who have received percutaneous coronary intervention
- Patients diagnosed with stroke, transient ischemic attack, or peripheral artery diseases
- Patients diagnosed with variant myocardial infarction
- Patients with severe liver or lung diseases or malignant tumors with life expectancy less than 3 years
- Patients with severe valvular heart disease
- Patients allergic or prohibited from using ezetimibe or rosuvastatin
- Patients with cardiogenic shock
- Pregnant women or women planning to become pregnant
- Patients receiving dialysis or who have had renal transplantation due to end-stage renal failure
- Patients who participated in other clinical studies within the past three months (except non-interventional studies)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 years
Participants take assigned study drugs daily for 3 years to evaluate the clinical utility of low-dose rosuvastatin plus ezetimibe combination therapy versus high-dose rosuvastatin monotherapy.
Visits at 6 weeks, 6 months, 12 months, and 36 months; follow-up through hospital or phone visits
Trial Site Locations
Total: 1 location
1
St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
Research Team
S
Sung-ho Her, MD.PhD
J
Jung Jin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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