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

Phase 4

Recruiting

• Conditions: Myocardial Infarction; Statin Adverse Reaction; HMG-CoA Reductase Inhibitor Toxicity
• Interventions: Drug: Ezetimibe 10mg + Rosuvastatin 5mg; Drug: Rosuvastatin 20mg

• Registration Number: NCT04499859
• Lead Sponsor: Kiyuk Chang, MD,PhD

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.

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Study Start: 2020-10-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3548

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ezetimibe 10 mg plus rosuvastatin 5 mg	Ezetimibe 10mg + Rosuvastatin 5mg	Rosuzet 5/10 mg , once a day for 24 months
rosuvastatin 20 mg only	Rosuvastatin 20mg	Any brand drugs of rosuvastatin 20mg, once a day for 24 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	3 months	LDL cholesterol level of 70mg/dL or less
cardiovascular death, non-fatal MI, or non-fatal stroke	24 months	cardiovascular death, non-fatal MI, or non-fatal stroke
Rate of Statin associated muscle symptoms	3 months	Stain Associated Muscle Symptom questionnaire

Trial Locations

Locations (7)

Bucheon St.Mary Hospital; 🇰🇷 Bucheon, Gyeonggido, Korea, Republic of

St.Vincent's Hospital; 🇰🇷 Suwon, Gyeonggido, Korea, Republic of

Uijeongbu St.Mary's Hospital; 🇰🇷 Uijeongbu, Gyeonggido, Korea, Republic of

Daejeon St.Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

Incheon St.Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of

Seoul St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Yeouido St.Mary Hospital; 🇰🇷 Seoul, Korea, Republic of