Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorKiyuk Chang, MD,PhD
About this trial
Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg.
This trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and ezetimibe among patients with acute myocardial infarction who went through percutaneous coronary intervention at decreasing major adverse cardiac events compared to the efficacy of single use of high dose rosuvastatin.
Eligibility criteria
Qualifiers
Adults Aged 19 and up
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)
For female patients who are of childbearing age, subjects that agreed on taking mandatory pregnancy test
Patients who agreed and signed on the informed consent form
Disqualifiers
Patients with life expectancy of a year or less due to malignancy
Patients with chronic liver disease
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.
Pregnant and/or breastfeeding
Trial design
Treatments tested in this trial
- Ezetimibe 10mg + Rosuvastatin 5mg
- Rosuvastatin 20mg
Treatment groups
3,548 Participants
are divided into 2 treatment groupsSponsors and collaborators
Kiyuk Chang, MD,PhD
Lead sponsor
The Catholic University of Korea
Sponsor institution
Source ClinicalTrials.gov