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

ConditionsMyocardial InfarctionStatin Adverse ReactionHMG-CoA Reductase Inhibitor Toxicity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorKiyuk Chang, MD,PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ezetimibe 10mg + Rosuvastatin 5mg

    Drug

    Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin

  • Rosuvastatin 20mg

    Drug

    20mg of Rosuvastatin as a standard treatment for AMI patients

Treatment groups

3,548 Participants
are divided into 2 treatment groups
Group A: ezetimibe 10 mg plus rosuvastatin 5 mgExperimental treatment 1 intervention
Group B: rosuvastatin 20 mg onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major Adverse Cardiovascular Events (MACE)

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.

Time frame
24 months

Secondary outcomes

1

death from any cause, a major coronary event, or a non-fatal stroke

death from any cause, a major coronary event, or a non-fatal stroke

Time frame
24 months
2

cardiovascular death, non-fatal MI, or non-fatal stroke

cardiovascular death, non-fatal MI, or non-fatal stroke

Time frame
24 months
3

all-cause death from any cause

Time frame
24months
4

cardiovascular death

Time frame
24months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kiyuk Chang, MD,PhD

Lead sponsor

The Catholic University of Korea

Sponsor institution

Source ClinicalTrials.gov
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