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

Myocardial Infarction Clinical Trial

— ROSUZET-AMI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499859
• Other study ID #: ROSUZET-AMI
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2022
• Source: The Catholic University of Korea
• Contact: Kiyuk Chang, MD,PhD
• Phone: 82-10-9175-2076
• Email: kiyuk[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3548
• Est. completion date: July 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HMG-CoA Reductase Inhibitor Toxicity
• Infarction
• Myocardial Infarction
• Statin Adverse Reaction

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St.Mary Hospital	Bucheon	Gyeonggido
Korea, Republic of	Daejeon St.Mary's Hospital	Daejeon
Korea, Republic of	Incheon St.Mary's Hospital	Incheon
Korea, Republic of	Seoul St.Mary's Hospital	Seoul
Korea, Republic of	Yeouido St.Mary Hospital	Seoul
Korea, Republic of	St.Vincent's Hospital	Suwon	Gyeonggido
Korea, Republic of	Uijeongbu St.Mary's Hospital	Uijeongbu	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Kiyuk Chang, MD,PhD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Revascularization	any revascularization	24 months
Secondary	LDL-C reduction	LDL cholesterol level of 70mg/dL or less	3 months
Secondary	Rate of Statin associated muscle symptoms	Stain Associated Muscle Symptom questionnaire	3 months