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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Statin Adverse Reaction; HMG-CoA Reductase Inhibitor Toxicity
• Intervention / Treatment: Drug: Ezetimibe 10mg + Rosuvastatin 5mg; Drug: Rosuvastatin 20mg

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 Type: Interventional
• Enrollment (Anticipated): 3548
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kiyuk Chang, MD,PhD; Phone Number: 82-10-9175-2076; Email: kiyuk@catholic.ac.kr
• Study Contact Backup: Name: Eun Ho Choo, MD; Phone Number: 82-10-8500-4569; Email: cmcchu@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Recruiting
    • Daejeon St.Mary's Hospital
    • Contact: Man Won Park, M.D.
  • Incheon, Korea, Republic of
    • Recruiting
    • Incheon St.Mary's Hospital
    • Contact: Doo Soo Jeon, M.D.
  • Seoul, Korea, Republic of, 137-701
    • Recruiting
    • Seoul St.Mary's Hospital
    • Principal Investigator: Kiyuk Chang, M.D.
  • Seoul, Korea, Republic of
    • Recruiting
    • Yeouido St.Mary Hospital
    • Contact: Chul-Soo Park, M.D.
  • Gyeonggido
    • Bucheon, Gyeonggido, Korea, Republic of
      • Recruiting
      • Bucheon St.Mary Hospital
      • Contact: Hee Yeol Kim, M.D.
    • Suwon, Gyeonggido, Korea, Republic of
      • Recruiting
      • St.Vincent's Hospital
      • Contact: Ki-Dong Yoo, M.D.
    • Uijeongbu, Gyeonggido, Korea, Republic of
      • Recruiting
      • Uijeongbu St.Mary's Hospital
      • Contact: Chan Joon Kim, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ezetimibe 10 mg plus rosuvastatin 5 mg; Rosuzet 5/10 mg , once a day for 24 months	Drug: Ezetimibe 10mg + Rosuvastatin 5mg; Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin; Other Names: Rosuzet 10/5 mg
Active Comparator: rosuvastatin 20 mg only; Any brand drugs of rosuvastatin 20mg, once a day for 24 months	Drug: Rosuvastatin 20mg; 20mg of Rosuvastatin as a standard treatment for AMI patients; Other Names: Crestor 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events (MACE)	A composite of cardiovascular death, non-fatal myocardial infarction, ischemic stroke and hospitalization due to unstable angina	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Each clinical outcome from MACE	Assessment variable including cardiovascular deaths, total deaths, non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization due to unstable angina	24 months
Revascularization	any revascularization	24 months
LDL-C reduction	LDL cholesterol level of 70mg/dL or less	3 months
Rate of Statin associated muscle symptoms	Stain Associated Muscle Symptom questionnaire	3 months

Collaborators and Investigators

• Sponsor: Kiyuk Chang, MD,PhD
• Investigators: Study Chair: Kiyuk Chang, MD,PhD, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Ezetimibe
• Other Study ID Numbers: ROSUZET-AMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes