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NCT06186037RecruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

\[Purpose of the Clinical Study\]: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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
6356 (estimated)
First submitted
21 Nov 2023
Start date
1 Feb 2024
Primary completion date
28 Feb 2029
Lead sponsor
Saint Vincent's Hospital, Korea
NCT number
NCT06186037

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 6356
  • From 1 Feb 2024 to the primary completion date, 28 Feb 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who received percutaneous coronary intervention
  • Patients who are receiving hemodialysis or peritoneal dialysis or received renal transplantation due to end-stage renal failure

Other illness

  • Patients diagnosed with acute coronary artery diseases (STEMI, NSTEMI, Unstable angina)
  • 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

Other

  • Patients with an intermediate (\>30%) lesion on the left main coronary artery.
  • 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 participated in other clinical studies within the past three months (except for non-interventional observation studies)

Who the study is looking for

  • 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.

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Vincent's Hospital
Coordinator of this site? Confirm its status
SuwonSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.