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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

300 Participants
are grouped into 1 trial group

Locations

16
Novartis Investigative Site428000, Cheboksary Russia
Novartis Investigative Site364051, Grozny Russia
Novartis Investigative Site650002, Kemerovo Russia
Novartis Investigative Site628012, Khanty-Mansiysk Russia

Sponsors and collaborators

Novartis Pharmaceuticals

Lead sponsor