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

Recruiting now

Conditions studied: Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT07142265

Run by

Novartis Pharmaceuticals

People needed

300

Starts

2025-09-30

Expected to finish

2027-09-30

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• Novartis Investigative Site — Cheboksary, Russia (enrolling)
• Novartis Investigative Site — Grozny, Russia (enrolling)
• Novartis Investigative Site — Kaluga, Russia (enrolling)
• Novartis Investigative Site — Kemerovo, Russia (enrolling)
• Novartis Investigative Site — Khanty-Mansiysk, Russia (enrolling)
• Novartis Investigative Site — Moscow, Russia (enrolling)
• Novartis Investigative Site — Moscow, Russia (enrolling)
• Novartis Investigative Site — Moscow, Russia (enrolling)
• Novartis Investigative Site — Novosibirsk, Russia (enrolling)
• Novartis Investigative Site — Orenburg, Russia (enrolling)
• Novartis Investigative Site — Penza, Russia (enrolling)
• Novartis Investigative Site — Petrozavodsk, Russia (enrolling)
• Novartis Investigative Site — Rostov-on-Don, Russia (enrolling)
• Novartis Investigative Site — S Petersburg, Russia (enrolling)
• Novartis Investigative Site — Samara, Russia (enrolling)
• Novartis Investigative Site — Syktyvkar, Russia (enrolling)
• Novartis Investigative Site — Tomsk, Russia (enrolling)
• Novartis Investigative Site — Ulan-Ude, Russia (enrolling)

Full record on ClinicalTrials.gov

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