Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI (ROSUZET-AMI)

Kiyuk Chang, MD,PhD

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Ezetimibe 10mg + Rosuvastatin 5mg; Drug: Rosuvastatin 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04499859

ROSUZET-AMI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,548 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,548 participants in 2 patient groups

ezetimibe 10 mg plus rosuvastatin 5 mg

Experimental group

Description:

Rosuzet 5/10 mg , once a day for 24 months

Treatment:

Drug: Ezetimibe 10mg + Rosuvastatin 5mg

rosuvastatin 20 mg only

Active Comparator group

Description:

Any brand drugs of rosuvastatin 20mg, once a day for 24 months

Treatment:

Drug: Rosuvastatin 20mg