Last Update: Dec 05, 2025
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
ClinicalTrials.gov Identifier:
Novartis Reference Number:CKJX839D1RU01
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Myocardial Infarction
Recruiting
300
Sep 30, 2025
Mar 31, 2027
All
18 Years - 100 Years (Adult, Older Adult)

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

Novartis Investigative Site

Recruiting

Petrozavodsk,185019,Russia

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