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 | Recruiting Phase 4

• 1 other identifier: XC23MIDV0033
• Study Type: interventional
• Target: 6,356
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease; Dyslipidemias; Primary Prevention

Keywords

Coronary Artery Disease; Dyslipidemias; Primary Prevention

Outcome Measures

Primary Outcomes (1)

• The occurrence rates of the compound variables

  The occurrence rates of the compound variables of all cause deaths, cardiac deaths, non-fatal myocardial infarction, non-fatal stroke, hospitalization due to unstable angina, and revascularization after taking the study medicine at the time of Visit 5 (36 month) were compared between groups

  Visit 5 (36month)

Study Arms (2)

Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg

EXPERIMENTAL

Ezetimibe 10 mg/Rosuvastatin 5 mg, Oral administration once a day, taking it for 3 years

Drug: Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg

Mono drug group of Rosuvastatin 20 mg

ACTIVE COMPARATOR

Rosuvastatin 20 mg , Oral administration once a day, taking it for 3 years

Drug: Mono drug group of Rosuvastatin 20 mg

Interventions

Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg DRUG

Oral administration once a day, taking it for 3 years

Combination drug group of Ezetimibe 10 mg/Rosuvastatin 5 mg

Mono drug group of Rosuvastatin 20 mg DRUG

Oral administration once a day, taking it for 3 years

Mono drug group of Rosuvastatin 20 mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adjusts (19 or older)
• Patients with suspected stable angina pectoris without coronary artery interventions, who showed a minimal to intermediate coronary artery diseases (a stenosis of 10 to 70% diameter as per QCA) in at least one natural coronary artery in coronary artery angiography or coronary artery CT.
• Patients who gave their informed consent themselves in writing.
• Patients who were treated with statin or lipid-lowering agents may participate in the study by changing the existing medicines.

You may not qualify if:

• Patients with an intermediate (\>30%) lesion on the left main coronary artery.
• Patients diagnosed with acute coronary artery diseases (STEMI, NSTEMI, Unstable angina)
• Patients who received percutaneous coronary intervention
• Patients who have been diagnosed with stroke, transitory ischemic attack, and peripheral artery diseases.
• Patients diagnosed with variant myocardial infarction
• Patients with severe liver diseases or lung diseases and/or malignant tumor with life expectancy of less than 3 years
• Patients with severe valvular heart disease
• Patients who are hypersensitive or prohibited from using the active substance (Ezetimibe or Rosuvastatin) of the study medicines
• Patients with cardiogenic shock
• Pregnant women or women who are planning to get pregnant
• Patients who are receiving hemodialysis or peritoneal dialysis or received renal transplantation due to end-stage renal failure
• Patients who participated in other clinical studies within the past three months (except for non-interventional observation studies)

Sponsors & Collaborators

• Saint Vincent's Hospital, Korea: lead

Study Sites (1)

St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Dyslipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sung-ho Her, MD.PhD

  St Vincent's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung-ho Her, MD.PhD

CONTACT

821077310052; hhhsungho@naver.com

Jung Jin, MD

CONTACT

821087238603; colaking@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 29, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: June 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)