About this trial
Evaluation of clinical outcomes during 12 months after inclisiran initiation in patients after STEMI/non-STEMI in real-world settings in Russia. It is also planned to study the therapy effect on the lipid profile characteristics, its safety, the state of atherosclerotic plaques according to carotid ultrasound, the frequency of hospitalizations and the need for intensive follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients of both genders
Myocardial Infarction diagnosis
Dyslipidemia diagnosis
The first injection of inclisiran no later than 14 ± 5 days after the STEMI/non-STEMI
Disqualifiers
Severe oncological and somatic diseases with system and organ failure*
Competing diseases that caused emergency hospitalization (pulmonary thromboembolism, aortic dissection)
History of therapy with PCSK9 inhibitors
Active inflammatory liver disease or the levels of AST, ALT > 3 times, or total bilirubin > 2 times higher than the upper limit of norm
Trial population
The study will include patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI. Index event is a first diagnosed STEMI/non-STEMI.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events registered within 12 months after inclisiran initiation in addition to basic therapy
Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events (cardiac death, nonfatal MI, nonfatal ischemic stroke, and hospitalization for unstable angina) registered within 12 months after the start of inclisiran therapy prescribed in addition to basic LLT
Secondary outcomes
Change and absolute change in lipid profile parameters
Change and absolute change in lipid profile parameters (total cholesterol, LDL-C, HDL-C, non-HDL-C, triglycerides, lipoprotein (a)) at 3, 9, and 12 months
Change and absolute change in lipid profile parameters in patients subgroups
Change and absolute change in lipid profile parameters at 3, 9, and 12 months in each of the 3 groups of patients identified on the basis of therapy and LDL-C level at admission: 1. Patients who have not previously received statins, with LDL-C level \> 5 mmol/L; 2. Patients receiving MTD statin therapy with LDL-C level of \> 2.5 mmol/L; 3. Patients receiving MTD statin therapy + ezetimibe who not at LDL-C target (\> 1.4 mmol/L) or did not achieve a 50% reduction in LDL-C level
Change in LDL-C level
Change in LDL-C level at Day 28 from baseline
The proportion of patients who maintain the target LDL-C level
The proportion of patients who maintain the target LDL-C level achieved after 3 months throughout the study period (12 months)
Sponsors and contacts
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