Myocardial Infarction
Conditions
Keywords
Myocardial infarction, NIS, inclisiran
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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 * LDL-C \> 5 mmol/L (statin-naive patients) or LDL-C \> 2.5 mmol/L (on the basis of statin MTD) at the time of hospitalization or no target LDL-C level (\> 1.4 mmol/L or no LDL-C level decrease by 50% on statin MTD + ezetimibe) * Signed Informed Consent Form (ICF)
Exclusion criteria
* 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 * Any other MACE in the anamnesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events registered within 12 months after inclisiran initiation in addition to basic therapy | 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change and absolute change in lipid profile parameters | Baseline, month 3, month 9, month 12 | 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 | Baseline, month 3, month 9, month 12 | 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 | Baseline, Day 28 | Change in LDL-C level at Day 28 from baseline |
| The proportion of patients who maintain the target LDL-C level | Month 3, Month 12 | The proportion of patients who maintain the target LDL-C level achieved after 3 months throughout the study period (12 months) |
| The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L | Day 28 , Month 12 | The proportion of patients who achieved the target LDL-C level of \< 1.4 mmol/L at Day 28 and at 12 months |
| The proportion of patients with progression and regression/no changes in atherosclerotic plaque | Baseline, Month 12 | The proportion of patients with progression and regression/no changes in atherosclerotic plaque determined on the basis of changes in its maximum height (mm) by carotid ultrasound at 12 months compared to 3-5 days after ACS (Acute Coronary Syndrome) |
| Number (%) of patients who achieved the target LDL-C level of < 1.4 mmol/L and with change in the maximum plaque height (mm) | 12 months | The correlation between the achievement of the target LDL-C level of \< 1.4 mmol/L and a change in the maximum plaque height (mm) is going to be measured. |
| Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE) | Month 3, Month 9, Month 12 | Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE) at 3, 9, and 12 months |
| The number of patients who discontinued inclisiran therapy due to AEs | Month 3, Moth 9, Month 12 | The number of patients who discontinued inclisiran therapy due to AEs at 3, 9, and 12 months |
| The number of patients re-hospitalized for CV events during the year | 12 months | The number of patients re-hospitalized for cardiovascular (CV) events during the year |
| The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization | 12 months | The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization |
| Number of patients who sought emergency care after the baseline visit | 12 months | Number of patients who sought emergency care after the baseline visit |
| The number of patients placed under dispensary observation | 12 months | The number of patients placed under dispensary observation |
| Number of days from the date of hospital discharge to place under dispensary observation | 12 months | Number of days from the date of hospital discharge to place under dispensary observation |
Countries
Russia
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed