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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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STEMI/Non-STEMI

Patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No