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

Launched by SAINT VINCENT'S HOSPITAL, KOREA · Dec 15, 2023

Keywords

ClinConnect Summary

This clinical trial is comparing two different treatments for patients with minimal to intermediate coronary artery disease, which is a condition where the blood vessels that supply the heart become narrowed. The researchers want to find out if a combination of low-dose rosuvastatin and ezetimibe is just as effective as taking a high dose of rosuvastatin alone in reducing serious heart-related events, like heart attacks. The goal is to ensure that the combination treatment is not worse than the high-dose treatment.

To be eligible to participate, you must be at least 19 years old and have stable chest pain (known as angina) without having had any recent heart procedures. You should also have a certain level of narrowing in your coronary arteries as shown by imaging tests. Participants can expect to be closely monitored during the trial, and they will need to give written consent to join. It's important to note that there are specific criteria that could exclude someone from the trial, such as having severe heart or liver problems, recent heart attacks, or being pregnant. If you meet the criteria, this trial may provide valuable information about effective treatments for heart disease.

Gender

ALL

Eligibility 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)