Actively 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
Led by Saint Vincent's Hospital, Korea · Updated on 2025-06-25
6356
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
\[Purpose of the Clinical Study\]: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.
CONDITIONS
Official 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 suspected stable angina pectoris without coronary artery interventions
- Presence of minimal to intermediate coronary artery disease (10 to 70% stenosis) in at least one natural coronary artery confirmed by coronary angiography or CT
- Patients who provide written informed consent
- Patients previously treated with statins or lipid-lowering agents can participate by switching medications
You will not qualify if you...
- 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 have undergone 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 tumor with life expectancy under 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 pregnancy
- Patients receiving hemodialysis or peritoneal dialysis or with renal transplantation due to end-stage renal failure
- Patients who participated in other clinical studies within the past 3 months except non-interventional observational studies
AI-Screening
AI-Powered Screening
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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
CONTACT
J
Jung Jin, MD
CONTACT
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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