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

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.

Primary outcome measures

• Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events registered within 12 months after inclisiran initiation in addition to basic therapy [Time frame: 12 months]

Secondary outcome measures (12)

• Change and absolute change in lipid profile parameters [Time frame: Baseline, month 3, month 9, month 12]
• Change and absolute change in lipid profile parameters in patients subgroups [Time frame: Baseline, month 3, month 9, month 12]
• Change in LDL-C level [Time frame: Baseline, Day 28]
• The proportion of patients who maintain the target LDL-C level [Time frame: Month 3, Month 12]
• The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L [Time frame: Day 28 , Month 12]
• The proportion of patients with progression and regression/no changes in atherosclerotic plaque [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) [Time frame: 12 months]
• Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE) [Time frame: Month 3, Month 9, Month 12]
• The number of patients who discontinued inclisiran therapy due to AEs [Time frame: Month 3, Moth 9, Month 12]
• The number of patients re-hospitalized for 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Russia · 16 centers

• Novartis Investigative Site — Cheboksary
• Novartis Investigative Site — Grozny
• Novartis Investigative Site — Kemerovo
• Novartis Investigative Site — Khanty-Mansiysk
• Novartis Investigative Site — Moscow
• Novartis Investigative Site — Moscow
• Novartis Investigative Site — Moscow
• Novartis Investigative Site — Novosibirsk
• … and 8 more centers

Identifiers

NCT: NCT07142265 · CKJX839D1RU01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗