Clinical trial NCT04499859: Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Myocardial Infarction
Statin Adverse Reaction
HMG-CoA Reductase Inhibitor Toxicity
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 3548
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Major Adverse Cardiovascular Events (MACE)
timeFrame: 24 months
Secondary outcomes:
measure: death from any cause, a major coronary event, or a non-fatal stroke
timeFrame: 24 months
measure: cardiovascular death, non-fatal MI, or non-fatal stroke
timeFrame: 24 months
measure: LDL-C reduction
timeFrame: 3 months
measure: Rate of Statin associated muscle symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon St.Mary Hospital
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: St.Vincent's Hospital
state: Gyeonggido
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St.Mary's Hospital
state: Gyeonggido
city: Daejeon
country: Korea, Republic of
facility: Daejeon St.Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Incheon St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yeouido St.Mary Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Kiyuk Chang, MD,PhD
role: STUDY_CHAIR
References: