Status:
RECRUITING
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
Lead Sponsor:
Kiyuk Chang, MD,PhD
Conditions:
Myocardial Infarction
Statin Adverse Reaction
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief 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 no...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2027
Estimated Enrollment :
3548 Patients enrolled
Trial Details
Trial ID
NCT04499859
Start Date
October 1 2020
End Date
August 30 2027
Last Update
July 30 2025
Active Locations (7)
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1
Bucheon St.Mary Hospital
Bucheon-si, Gyeonggido, South Korea
2
St.Vincent's Hospital
Suwon, Gyeonggido, South Korea
3
Uijeongbu St.Mary's Hospital
Uijeongbu-si, Gyeonggido, South Korea
4
Daejeon St.Mary's Hospital
Daejeon, South Korea