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

Обзор

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.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Россия · 16 центров

• 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
• … и ещё 8 центров

Идентификаторы

NCT: NCT07142265 · CKJX839D1RU01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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