Early inclisiran after a heart attack: one-year outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, real‑world registry will follow adults in Russia who receive their first inclisiran injection within 14 ± 5 days after a STEMI or non‑STEMI and meet dyslipidemia LDL thresholds. Patients will be followed for 12 months to track changes in lipid profile, safety signals, carotid ultrasound measures of atherosclerotic plaque, hospitalizations, and need for intensified follow‑up. Key exclusions include prior PCSK9 inhibitor therapy, active inflammatory liver disease or markedly elevated liver tests, severe comorbid organ failure, and prior major adverse cardiovascular events. Data will reflect routine clinical care at participating Novartis investigational sites and describe outcomes in a post‑MI population receiving early inclisiran.

Why it matters

Who can join: the full rules

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

Where it's running

• Novartis Investigative Site
  Cheboksary, Russia Recruiting
• Novartis Investigative Site
  Grozny, Russia Recruiting
• 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

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.