Menu
Recruiting NCT04499859

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

Phase IV Interventional Myocardial Infarction Statin Adverse Reaction HMG-CoA Reductase Inhibitor Toxicity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ezetimibe 10mg + Rosuvastatin 5mg, Rosuvastatin 20mg.
Who it may be relevant to
Registry conditions: Myocardial Infarction, Statin Adverse Reaction, HMG-CoA Reductase Inhibitor Toxicity. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Ezetimibe 10mg + Rosuvastatin 5mg
    Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
  • Drug Rosuvastatin 20mg
    20mg of Rosuvastatin as a standard treatment for AMI patients

Primary outcome measures

  • Major Adverse Cardiovascular Events (MACE) [Time frame: 24 months]
Secondary outcome measures (12)
  • death from any cause, a major coronary event, or a non-fatal stroke [Time frame: 24 months]
  • cardiovascular death, non-fatal MI, or non-fatal stroke [Time frame: 24 months]
  • all-cause death from any cause [Time frame: 24months]
  • cardiovascular death [Time frame: 24months]
  • any myocardial infaction [Time frame: 24 months]
  • any stroke [Time frame: 24 months]
  • any revascularization occurring at least 30 days after randomization [Time frame: 24 months]
  • LDL-C reduction <= 70mg/dl [Time frame: 3 months]
  • LDL-C reduction <= 55mg/dl [Time frame: 3 months]
  • Rate of Statin associated muscle symptoms [Time frame: 3 months]
  • drug discontinuation or dose reduction [Time frame: 24 months]
  • pill count drug adherence [Time frame: 24 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 7 centers
  • Bucheon St.Mary Hospital — Bucheon-si
  • St.Vincent's Hospital — Suwon
  • Uijeongbu St.Mary's Hospital — Uijeongbu-si
  • Daejeon St.Mary's Hospital — Daejeon
  • Incheon St.Mary's Hospital — Incheon
  • Seoul St.Mary's Hospital — Seoul
  • Yeouido St.Mary Hospital — Seoul

Publications

  • Choo EH, Kim CJ, Hwang BH, Lee KY, Oh GC, Lim S, Choi IJ, Kim DB, Kwon OS, Lee S, Choi Y, Park CS, Park MW, Kim HY, Lee HC, Kang TS, Sung JK, Woo SI, Park HS, Yun KH, Chang K; ROSUZET-AMI investigator. High-Intensity Statin versus Upfront Equivalent-Dose Combination of Moderate-Intensity Statin with Ezetimibe Following Acute Myocardial Infarction (ROSUZET-AMI): protocol of a multicentre, open-labe PMID 41198200

Identifiers

NCT: NCT04499859 · ROSUZET-AMI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗