NCT04499859 Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI
| NCT ID | NCT04499859 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Kiyuk Chang, MD,PhD |
| Condition | Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,548 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,548 participants in total. It began in 2020-10-01 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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)
Contact & Investigator
Kiyuk Chang, MD,PhD
STUDY CHAIR
Seoul St. Mary's Hospital
Frequently Asked Questions
Who can join the NCT04499859 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04499859 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04499859 currently recruiting?
Yes, NCT04499859 is actively recruiting participants. Contact the research team at kiyuk@catholic.ac.kr for enrollment information.
Where is the NCT04499859 trial being conducted?
This trial is being conducted at Bucheon-si, South Korea, Suwon, South Korea, Uijeongbu-si, South Korea, Daejeon, South Korea and 3 additional locations.
Who is sponsoring the NCT04499859 clinical trial?
NCT04499859 is sponsored by Kiyuk Chang, MD,PhD. The principal investigator is Kiyuk Chang, MD,PhD at Seoul St. Mary's Hospital. The trial plans to enroll 3,548 participants.