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RECRUITING
NCT06186037
PHASE4

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

Sponsor: Saint Vincent's Hospital, Korea

View on ClinicalTrials.gov

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.

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 : A Prospective, Multicenter, Randomized, Open-label Trial

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6356

Start Date

2024-02-01

Completion Date

2029-02-28

Last Updated

2025-06-25

Healthy Volunteers

No

Interventions

DRUG

Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg

Oral administration once a day, taking it for 3 years

DRUG

Mono drug group of Rosuvastatin 20 mg

Oral administration once a day, taking it for 3 years

Locations (1)

St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea