 Last Update: Aug 10, 2026 

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

ClinicalTrials.gov Identifier: [NCT07142265](https://clinicaltrials.gov/ct2/show/NCT07142265)

 

Novartis Reference Number:CKJX839D1RU01

 

 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") 

 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.



 

 Condition Myocardial Infarction 

 

 Overall Status Recruiting 

 

 Number of Participants300

 

 

 Start Date Sep 30, 2025 

 

 Completion Date Sep 30, 2027 

 

 Gender All 

 

 Age(s) 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 \\&gt; 5 mmol/L (statin-naive patients) or LDL-C \\&gt; 2.5 mmol/L (on the basis of statin MTD) at the time of hospitalization or no target LDL-C level (\\&gt; 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 \\&gt; 3 times, or total bilirubin \\&gt; 2 times higher than the upper limit of norm  
\* Any other MACE in the anamnesis



 

 Russia 

####  Novartis Investigative Site 

Recruiting

 Penza,440026,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Orenburg,460018,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Kaluga,248000,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Samara,443070,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Moscow,121552,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Khanty-Mansiysk,628012,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Tomsk,634009,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Syktyvkar,167981,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 S Petersburg,192242,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Petrozavodsk,185019,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Moscow,119607,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Grozny,364051,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Ulan-Ude,670031,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Rostov-on-Don,344010,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Novosibirsk,630051,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Moscow,105203,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Kemerovo,650002,Russia

 

 

 

 

####  Novartis Investigative Site 

Recruiting

 Cheboksary,428000,Russia

 

 

 

 

 

 

 

 

 

##  Worldwide Contacts 

If the location of your choosing does not feature any contact detail, please reach out using the information below.

#### Novartis Pharmaceuticals

Phone: [ +41613241111](tel:+41613241111) 

Email: <novartis.email@novartis.com>