RecruitingPhase 4NCT04499859

Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in 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


Sponsor

Kiyuk Chang, MD,PhD

Enrollment

3,548 participants

Start Date

Oct 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two cholesterol-lowering strategies after a heart attack: a low-dose combination of rosuvastatin and ezetimibe versus a high-dose rosuvastatin alone. After a heart attack treated with a stent procedure (PCI), patients need effective cholesterol control to prevent future events. This study tests whether combining two drugs at lower doses is just as effective — and perhaps better tolerated — than using one drug at a higher dose. Participants are adults 19 and older who were treated with PCI for a heart attack (STEMI or NSTEMI). Women of childbearing age must agree to pregnancy testing. You may be eligible if: - You are 19 years or older - You were diagnosed with a heart attack (ST-elevation or non-ST-elevation) and treated with percutaneous coronary intervention (PCI/stent) - You can provide informed consent You may NOT be eligible if: - You have a life expectancy of 1 year or less due to cancer - You have chronic liver disease - You are allergic to rosuvastatin or ezetimibe, or cannot take them - You are pregnant or breastfeeding - You cannot use any form of contraception (for women of childbearing age) - You are on dialysis or have had a kidney transplant - You participated in another clinical trial within the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEzetimibe 10mg + Rosuvastatin 5mg

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

DRUGRosuvastatin 20mg

20mg of Rosuvastatin as a standard treatment for AMI patients


Locations(7)

Bucheon St.Mary Hospital

Bucheon-si, Gyeonggido, South Korea

St.Vincent's Hospital

Suwon, Gyeonggido, South Korea

Uijeongbu St.Mary's Hospital

Uijeongbu-si, Gyeonggido, South Korea

Daejeon St.Mary's Hospital

Daejeon, South Korea

Incheon St.Mary's Hospital

Incheon, South Korea

Seoul St.Mary's Hospital

Seoul, South Korea

Yeouido St.Mary Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT04499859


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