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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 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6356

Last updated 2025-06-25

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Saint Vincent's Hospital, Korea

    lead OTHER

Principal Investigators

  • Sung-ho Her, MD.PhD · St Vincent's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2029-02-28
Completion
2029-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06186037 on ClinicalTrials.gov