Using evolocumab to lower cholesterol in patients with vulnerable plaques after heart surgery
A Single-center, Randomized, Parallel-group, Open-label Pilot Study to Evaluate the Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patients Who Underwent Percutaneous Coronary Intervention for the Acute Coronary Syndrome
This study tests if a cholesterol-lowering drug called evolocumab can help patients with vulnerable heart plaques after heart surgery feel safer and have fewer heart problems over the next year.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Korea University Anam Hospital Academic / other |
| Drugs / interventions | evolocumab |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04719221 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of evolocumab, an intensive cholesterol-lowering therapy, on patients who have undergone percutaneous coronary intervention for acute coronary syndrome. It focuses on assessing changes in the Lipid Core Burden Index of non-culprit vulnerable plaques and compares the rate of cardiac events over a 12-month period following treatment. The study aims to determine if this therapy can effectively reduce the risk associated with high-risk plaques. Participants will be monitored closely to evaluate the impact of the treatment on their cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 who have undergone coronary stent surgery for acute coronary syndrome and have high LDL cholesterol levels despite maximum therapy.
Not a fit: Patients with known hypersensitivity to the study medications or those who are pregnant or planning to become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of cardiac events in patients with vulnerable plaques.
How similar studies have performed: Other studies have shown promising results with similar cholesterol-lowering therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Over 19 years old 2. Patients who agree to the study plan and clinical follow-up plan, voluntarily decide to participate in this study, and consent in writing to the consent to use information 3. Patients who underwent NIRS-IVUS guided coronary stent surgery for acute coronary syndrome 4. Patients who did not meet the LDL-Cholesterol level (\<70mg/dL) even after receiving the maximum dose of combined cholesterol therapy for 2 months Exclusion Criteria: 1. Subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, ticagrelor, prasugrel, rosuvastatin, ezetimibe, evolocumab, lansoprazole, cobalt chromium, stainless steel nickel And contrast agents (however, even a subject who is hypersensitive to contrast agents can register if they can be controlled by steroids and pheniramine, except for known anaphylaxis.) 2. Pregnant women, lactating women, or women of childbearing age who plan to become pregnant during this study 3. Subjects who plan to have surgery to stop antiplatelet drugs within 12 months from registration 4. Those whose surviving life is expected to be less than 1 year 5. Subjects who visited the hospital due to psychogenic shock and are predicted to have low survival probability based on medical judgment 6. Subjects participating in a randomized study on cholesterol therapy
Where this trial is running
Seoul
- Korea University Anam Hospital — Seoul, Korea, Republic of (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.