Comparison of low-dose rosuvastatin with ezetimibe versus high-dose rosuvastatin for coronary artery disease
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
This study is testing whether a low-dose combination of rosuvastatin and ezetimibe can help people with coronary artery disease just as well as high-dose rosuvastatin alone, while also looking for fewer side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 6356 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Saint Vincent's Hospital, Korea Academic / other |
| Locations | 1 site (Suwon, Gyeonggi-do) |
| Trial ID | NCT06186037 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of a low-dose combination of rosuvastatin and ezetimibe against high-dose rosuvastatin monotherapy in patients with minimal to intermediate coronary artery disease who have not undergone percutaneous coronary intervention. The study will assess whether the combination therapy is non-inferior in reducing major cardiovascular events compared to the high-dose treatment. It addresses the potential for fewer adverse effects associated with the combination therapy, particularly in East Asian populations. Participants will be monitored for key cardiovascular outcomes over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 or older with minimal to intermediate coronary artery disease and suspected stable angina pectoris.
Not a fit: Patients with severe coronary artery disease, recent acute coronary events, or those who have undergone percutaneous coronary intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and equally effective treatment option for patients with coronary artery disease.
How similar studies have performed: While high-dose statin therapies are well-established, the combination of low-dose statin and ezetimibe is being explored for its potential benefits, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female adjusts (19 or older) 2. 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. 3. Patients who gave their informed consent themselves in writing. 4. Patients who were treated with statin or lipid-lowering agents may participate in the study by changing the existing medicines. Exclusion Criteria: 1. Patients with an intermediate (\>30%) lesion on the left main coronary artery. 2. Patients diagnosed with acute coronary artery diseases (STEMI, NSTEMI, Unstable angina) 3. Patients who received percutaneous coronary intervention 4. Patients who have been diagnosed with stroke, transitory ischemic attack, and peripheral artery diseases. 5. Patients diagnosed with variant myocardial infarction 6. Patients with severe liver diseases or lung diseases and/or malignant tumor with life expectancy of less than 3 years 7. Patients with severe valvular heart disease 8. Patients who are hypersensitive or prohibited from using the active substance (Ezetimibe or Rosuvastatin) of the study medicines 9. Patients with cardiogenic shock 10. Pregnant women or women who are planning to get pregnant 11. Patients who are receiving hemodialysis or peritoneal dialysis or received renal transplantation due to end-stage renal failure 12. Patients who participated in other clinical studies within the past three months (except for non-interventional observation studies)
Where this trial is running
Suwon, Gyeonggi-do
- St. Vincent's Hospital — Suwon, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Sung-ho Her, MD.PhD — St Vincent's Hospital
- Study coordinator: Sung-ho Her, MD.PhD
- Email: hhhsungho@naver.com
- Phone: 821077310052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.