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NCT05624658
Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS
Conditions: Dyslipidemias
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 200
Sponsor: Samara Regional Cardiology Dispensary
Location: Russian Federation
Summary
The study is prospective, open-label, randomized, single-center study involving patients admitted on an emergency basis with an acute coronary syndrome (ACS) clinic who underwent PCI of an infarct-related artery (IRA) and had intermediate coronary artery lesions (50-70% stenosis diameter) and elevated LDL-C ( > 1.4 mmol/l) despite statin therapy at the highest dosage.
Patients who showed high compliance and did not reach the target LDL-C values 1 month after the development of ACS on the 2nd visit will be randomized into two groups of 60 patients each.
Group 1 - taking PCSK9 inhibitors (Alirocumab 150 mg by subcutaneous injection once every 2 weeks or Evolocumab 140 mg by subcutaneous injection once every 2 weeks - open-label prescription of drugs) while taking Atorvastatin at a dose of 80 mg / day.
Group 2 - receiving Ezetimibe at a dose of 10 mg in combination with Atorvastatin 80 mg / day.
Eligibility Criteria
Inclusion Criteria:gender (any);age 18-75 years;admission < 24 hours after pain onsetacute 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 admissionfailure to achieve the target level of LDL-C ≥1.4 mmol/l on the second visit;signed informed consentExclusion Criteria:previous MIhistory of revascularization (PCI/CABG)presence of non-IRA stenoses ≥50%.multivessel lesion, including significant stenosis of the LMEF < 40%,Killip III-IV.NYHA III-IVsignificant calcification or tortuosity of the coronary arteries, limiting OCTintolerance to statins, aspirin, P2Y12 inhibitorspatients who have previously received PCSK9 inhibitors and/or Ezetimibtreatment with systemic steroids or systemic cyclosporine within the last 3 monthscollagenoses and inflammatory diseases,oncological diseases within the last 5 years,scheduled surgery within 3 monthspersons suffering from mental disorderspregnancy, breastfeeding period
Source: ClinicalTrials.gov (NCT05624658). StuddyBuddy aggregates publicly available trial information.