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NCT Number: NCT04499859

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases HMG-CoA Reductase Inhibitor Toxicity Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Statin Adverse Reaction Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bucheon St.Mary Hospital, Bucheon-si, Gyeonggido, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Female patients who are unable to use any means of contraception
  • Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant patients, due to end stage renal disease
  • Patients who participated in other clinical trial(s) within 3 months from the screening (except non-interventional observational study)
  • Patients considered inappropriate for the study for any other reason(s) by the inspector(s)

Treatment and study plan

Ezetimibe 10mg + Rosuvastatin 5mg

Drug

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

Other names: Rosuzet 10/5 mg

Rosuvastatin 20mg

Drug

20mg of Rosuvastatin as a standard treatment for AMI patients

Other names: Crestor 20mg

Primary outcomes

  1. Major Adverse Cardiovascular Events (MACE)

    Time frame: 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 outcomes

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

    Time frame: 24 months

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

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

    Time frame: 24 months

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

  3. all-cause death from any cause

    Time frame: 24months

  4. cardiovascular death

    Time frame: 24months

  5. any myocardial infaction

    Time frame: 24 months

  6. any stroke

    Time frame: 24 months

  7. any revascularization occurring at least 30 days after randomization

    Time frame: 24 months

  8. LDL-C reduction <= 70mg/dl

    Time frame: 3 months

    LDL cholesterol level of 70mg/dL or less

  9. LDL-C reduction <= 55mg/dl

    Time frame: 3 months

  10. Rate of Statin associated muscle symptoms

    Time frame: 3 months

    Stain Associated Muscle Symptom questionnaire

  11. drug discontinuation or dose reduction

    Time frame: 24 months

  12. pill count drug adherence

    Time frame: 24 months

  13. new onset diabetes

    Time frame: 24 months

  14. cataract

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Eun Ho Choo, MD

CONTACT

[email protected]

82-10-8500-4569

Kiyuk Chang, MD,PhD

CONTACT

[email protected]

82-10-9175-2076

Sponsors and collaborators

Lead sponsor

Kiyuk Chang, MD,PhD

Other

Registry information

Official study 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

Acronym: ROSUZET-AMI

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Aug 5, 2020
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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