Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients

Novartis Pharmaceuticals300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Myocardial Infarction

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (18)

Novartis Investigative Site

Cheboksary, Russia

RECRUITING

Novartis Investigative Site

Grozny, Russia

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

Time frame: 12 months

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

Time frame: Baseline, month 3, month 9, month 12

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

Time frame: Baseline, month 3, month 9, month 12

Change in LDL-C level

Change in LDL-C level at Day 28 from baseline

Time frame: Baseline, Day 28

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)

Time frame: Month 3, Month 12

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Data from ClinicalTrials.gov

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Novartis Investigative Site

Kaluga, Russia

RECRUITING

Novartis Investigative Site

Kemerovo, Russia

RECRUITING

Novartis Investigative Site

Khanty-Mansiysk, Russia

RECRUITING

Novartis Investigative Site

Moscow, Russia

RECRUITING

Novartis Investigative Site

Moscow, Russia

RECRUITING

Novartis Investigative Site

Moscow, Russia

RECRUITING

Novartis Investigative Site

Novosibirsk, Russia

RECRUITING

Novartis Investigative Site

Orenburg, Russia

RECRUITING

...and 8 more locations

The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L

The proportion of patients who achieved the target LDL-C level of \< 1.4 mmol/L at Day 28 and at 12 months

Time frame: Day 28 , Month 12

The proportion of patients with progression and regression/no changes in atherosclerotic plaque

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)

Time frame: Baseline, Month 12

Number (%) of patients who achieved the target LDL-C level of < 1.4 mmol/L and with change in the maximum plaque height (mm)

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.

Time frame: 12 months

Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE)

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

Time frame: Month 3, Month 9, Month 12

The number of patients who discontinued inclisiran therapy due to AEs

The number of patients who discontinued inclisiran therapy due to AEs at 3, 9, and 12 months

Time frame: Month 3, Moth 9, Month 12

The number of patients re-hospitalized for CV events during the year

The number of patients re-hospitalized for cardiovascular (CV) events during the year

Time frame: 12 months

The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization

Time frame: 12 months

Number of patients who sought emergency care after the baseline visit

Time frame: 12 months

The number of patients placed under dispensary observation

Time frame: 12 months

Number of days from the date of hospital discharge to place under dispensary observation

Time frame: 12 months