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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study showed that even when statin is not used as a treatment the rate of decrease of LDL cholesterol is correlated to the risk of heart disease. Yet whether concomitant use of ezetimibe and statin will have similar degree of clinical efficacy as single use of high dose statin in decreasing LDL cholesterol level needs further examination.

Official Title
-----------------
A Prospective, Multicenter, Randomized, Open-label Trial to Compare Low-dose ROSUvastatin Plus eZETimibe Versus High-dose Rosuvastatin in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention

Conditions
-----------------
Myocardial Infarction, Statin Adverse Reaction, HMG-CoA Reductase Inhibitor Toxicity

Intervention / Treatment
-----------------
* Drug: Ezetimibe 10mg + Rosuvastatin 5mg
* Drug: Rosuvastatin 20mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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 Female patients who are unable to use any means of contraception Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study) Patients considered inappropriate for the study for any other reason(s) by the inspector(s)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ezetimibe 10 mg plus rosuvastatin 5 mg<br>Rosuzet 5/10 mg , once a day for 24 months | Drug: Ezetimibe 10mg + Rosuvastatin 5mg<br>* Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin<br>* Other names: Rosuzet 10/5 mg;|
| Active Comparator: rosuvastatin 20 mg only<br>Any brand drugs of rosuvastatin 20mg, once a day for 24 months | Drug: Rosuvastatin 20mg<br>* 20mg of Rosuvastatin as a standard treatment for AMI patients<br>* Other names: Crestor 20mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events (MACE) | A composite of cardiovascular death, non-fatal myocardial infarction, ischemic stroke and hospitalization due to unstable angina | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Each clinical outcome from MACE | Assessment variable including cardiovascular deaths, total deaths, non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization due to unstable angina | 24 months | 
| Revascularization | any revascularization | 24 months | 
| LDL-C reduction | LDL cholesterol level of 70mg/dL or less | 3 months | 
| Rate of Statin associated muscle symptoms | Stain Associated Muscle Symptom questionnaire | 3 months |