Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI

Launched by KIYUK CHANG, MD,PHD · Aug 4, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a combination therapy using low doses of two medications, rosuvastatin and ezetimibe, compared to a higher dose of rosuvastatin alone. The goal is to see if taking the lower dose combination can effectively lower bad cholesterol (LDL cholesterol) just as well as the higher dose, while also reducing the risk of serious heart problems in patients who have had a heart attack and received a specific heart treatment called percutaneous coronary intervention.

To participate in this study, you need to be an adult aged 19 or older who has been diagnosed with a heart attack and has undergone the heart treatment mentioned. Additionally, if you are a woman of childbearing age, you must agree to take a pregnancy test. Participants will receive either the combination therapy or the higher dose of rosuvastatin and will be monitored for their health outcomes. It’s important to know that certain health conditions or recent participation in other clinical trials may prevent someone from joining. If you're considering joining, make sure to discuss it with your healthcare provider for more personalized advice.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults Aged 19 and up
• • 2. Patients diagnosed with myocardial infarction (both ST segment elevation and non-ST segment elevation) who were treated with percutaneous coronary intervention (Myocardial infarction defined as in the 4th Universal Definition of Myocardial Infarction)
• • 3. For female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test
• • 4. Patients who agreed and signed on the informed consent form
• Exclusion Criteria:
• • 1. Patients with life expectancy of a year or less due to malignancy
• • 2. Patients with chronic liver disease
• • 3. Patients with sensitivity to active ingredient of the research drugs (ezetimibe and/or rosuvastatin) or patients who are prohibited to take ezetimibe and/or rosuvastatin.
• • 4. Pregnant and/or breastfeeding
• • 5. Female patients who are unable to use any means of contraception
• • 6. Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease
• • 7. Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study)
• • 8. Patients considered inappropriate for the study for any other reason(s) by the inspector(s)