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

Recruitingn/aAges 18 Years - 100 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

18 sites
Novartis Investigative Site
Cheboksary, Russia
Novartis Investigative Site
Grozny, Russia
Novartis Investigative Site
Kaluga, Russia
Novartis Investigative Site
Kemerovo, Russia
Novartis Investigative Site
Khanty-Mansiysk, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Moscow, Russia

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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