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

NCT06186037

Phase 4 Recruiting 6356 enrolled Saint Vincent's Hospital, Korea
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

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg Oral
Comparator Rosuvastatin Small molecule 5 mg Oral
Comparator Rosuvastatin Small molecule 20 mg Oral