HMG-CoA Reductase Inhibitor Toxicity, Myocardial Infarction, Statin Adverse Reaction
Conditions
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.
Interventions
DRUGEzetimibe 10mg + Rosuvastatin 5mg
Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
DRUGRosuvastatin 20mg
20mg of Rosuvastatin as a standard treatment for AMI patients
Sponsors
Kiyuk Chang, MD,PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events (MACE) | 24 months | A composite of cardiovascular death, major coronary events (non-fatal MI, documented unstable angina requiring hospital admission, all coronary revascularization with either PCI or bypass surgery occurring at least 30 days after randomization), or non-fatal stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cardiovascular death, non-fatal MI, or non-fatal stroke | 24 months | cardiovascular death, non-fatal MI, or non-fatal stroke |
| all-cause death from any cause | 24months | — |
| cardiovascular death | 24months | — |
| any myocardial infaction | 24 months | — |
| any stroke | 24 months | — |
| any revascularization occurring at least 30 days after randomization | 24 months | — |
| death from any cause, a major coronary event, or a non-fatal stroke | 24 months | death from any cause, a major coronary event, or a non-fatal stroke |
| LDL-C reduction <= 55mg/dl | 3 months | — |
| Rate of Statin associated muscle symptoms | 3 months | Stain Associated Muscle Symptom questionnaire |
| drug discontinuation or dose reduction | 24 months | — |
| pill count drug adherence | 24 months | — |
| new onset diabetes | 24 months | — |
| cataract | 24 months | — |
| LDL-C reduction <= 70mg/dl | 3 months | LDL cholesterol level of 70mg/dL or less |
Countries
South Korea
Contacts
Primary ContactKiyuk Chang, MD,PhD
Backup ContactEun Ho Choo, MD
Outcome results
None listed