Impact of Lipid-lowering Therapy on Heart Health in Acute Coronary Syndrome Patients
Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With Acute Coronary Syndrome, a Prospective, Open-label, Randomized, Single-center Study
This study is testing whether adding new cholesterol-lowering medications to standard treatment can help heart patients with high cholesterol feel better and reduce heart risks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Samara Regional Cardiology Dispensary Academic / other |
| Drugs / interventions | Alirocumab, Evolocumab |
| Locations | 1 site (Samara) |
| Trial ID | NCT05624658 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of combined lipid-lowering therapies on patients with acute coronary syndrome (ACS) who have not achieved target LDL cholesterol levels despite maximum statin therapy. It involves a randomized, open-label design where patients will be assigned to receive either PCSK9 inhibitors or Ezetimibe alongside Atorvastatin. Participants will undergo various assessments, including coronary imaging and laboratory tests, to evaluate the effectiveness of the treatments over a follow-up period of 52 weeks. The goal is to determine which therapy better reduces atherosclerotic plaque vulnerability.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with acute coronary syndrome and elevated LDL cholesterol levels despite high-dose statin therapy.
Not a fit: Patients with a history of myocardial infarction, significant coronary artery disease, or those intolerant to statins or specific lipid-lowering medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of cholesterol levels and reduced risk of heart complications in patients with acute coronary syndrome.
How similar studies have performed: Other studies have shown promising results with PCSK9 inhibitors in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * gender (any); * age 18-75 years; * admission \< 24 hours after pain onset * acute coronary syndrome with at least one coronary artery stenosis requiring PCI; * one or two non-IRA (coronary artery lumen diameter according to CAG \>20% and \<50% and no need for revascularization within the next 6 months according to the investigator) * not taking statins for at least 3 (6) months or not achieving the target level of LDL-C at admission * failure to achieve the target level of LDL-C ≥1.4 mmol/l on the second visit; * signed informed consent Exclusion Criteria: * previous MI * history of revascularization (PCI/CABG) * presence of non-IRA stenoses ≥50%. * multivessel lesion, including significant stenosis of the LM * EF \< 40%, * Killip III-IV. * NYHA III-IV * significant calcification or tortuosity of the coronary arteries, limiting OCT * intolerance to statins, aspirin, P2Y12 inhibitors * patients who have previously received PCSK9 inhibitors and/or Ezetimib * treatment with systemic steroids or systemic cyclosporine within the last 3 months * collagenoses and inflammatory diseases, * oncological diseases within the last 5 years, * scheduled surgery within 3 months * persons suffering from mental disorders * pregnancy, breastfeeding period
Where this trial is running
Samara
- Samara Regional Cardiology Dispansery — Samara, Russian Federation (Recruiting)
Study contacts
- Principal investigator: Dmitry Duplyakov — Samara State Medical Universiry
- Study coordinator: Dmitry Duplyakov, professor
- Email: duplyakov@yahoo.com
- Phone: +79277297273
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.