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

This trial does not accept healthy volunteers

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 population

The study will include patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI. Index event is a first diagnosed STEMI/non-STEMI.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: STEMI/Non-STEMI

Trial outcomes

Primary outcomes

1

Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events registered within 12 months after inclisiran initiation in addition to basic therapy

Number of patients with Atherosclerotic Cardiovascular Disease (ASCVD) events (cardiac death, nonfatal MI, nonfatal ischemic stroke, and hospitalization for unstable angina) registered within 12 months after the start of inclisiran therapy prescribed in addition to basic LLT

Time frame
12 months

Secondary outcomes

1

Change and absolute change in lipid profile parameters

Change and absolute change in lipid profile parameters (total cholesterol, LDL-C, HDL-C, non-HDL-C, triglycerides, lipoprotein (a)) at 3, 9, and 12 months

Time frame
Baseline, month 3, month 9, month 12
2

Change and absolute change in lipid profile parameters in patients subgroups

Change and absolute change in lipid profile parameters at 3, 9, and 12 months in each of the 3 groups of patients identified on the basis of therapy and LDL-C level at admission: 1. Patients who have not previously received statins, with LDL-C level \> 5 mmol/L; 2. Patients receiving MTD statin therapy with LDL-C level of \> 2.5 mmol/L; 3. Patients receiving MTD statin therapy + ezetimibe who not at LDL-C target (\> 1.4 mmol/L) or did not achieve a 50% reduction in LDL-C level

Time frame
Baseline, month 3, month 9, month 12
3

Change in LDL-C level

Change in LDL-C level at Day 28 from baseline

Time frame
Baseline, Day 28
4

The proportion of patients who maintain the target LDL-C level

The proportion of patients who maintain the target LDL-C level achieved after 3 months throughout the study period (12 months)

Time frame
Month 3, Month 12

Other outcomes

Sponsors and contacts

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