Clinical Trial

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

Study acronym: ALMIGHTY
Recruiting Phase 4
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-12-15; most recent amendment 2025-06-19.
Status change: Not Yet Recruiting → Recruiting 2024-02-21
Trial Details
NCT Number NCT06186037
Lead Sponsor Saint Vincent's Hospital, Korea
Conditions Coronary Artery Disease, Dyslipidemias, Primary Prevention
Enrollment 6,356 participants
Start Date 2024-02-01
Primary Completion 2029-02-28 (estimated)
Study Completion 2029-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-06-25