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

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Myocardial Infarction

Countries: Russia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (18)

Cheboksary, Russia
Grozny, Russia
Kaluga, Russia
Kemerovo, Russia
Khanty-Mansiysk, Russia
Moscow, Russia
Moscow, Russia
Moscow, Russia
Novosibirsk, Russia
Orenburg, Russia
Penza, Russia
Petrozavodsk, Russia
Rostov-on-Don, Russia
S Petersburg, Russia
Samara, Russia
Syktyvkar, Russia
Tomsk, Russia
Ulan-Ude, Russia