drugset / Trial / NCT06186037
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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-02-01
- Primary completion
- 2029-02-28
- Completion
- 2029-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezetimibe | Unknown | 10 mg | Oral |
| Comparator | Rosuvastatin | Small molecule | 5 mg | Oral |
| Comparator | Rosuvastatin | Small molecule | 20 mg | Oral |