Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT05624658
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05624658
Study Brief:
Protocol Section:
NCT05624658