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NCT Number: NCT07142265

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

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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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Cheboksary, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 12 months

    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

Secondary outcomes

  1. Change and absolute change in lipid profile parameters

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

    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

  2. Change and absolute change in lipid profile parameters in patients subgroups

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

    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:

    • Patients who have not previously received statins, with LDL-C level > 5 mmol/L;
    • Patients receiving MTD statin therapy with LDL-C level of > 2.5 mmol/L;
    • 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

  3. Change in LDL-C level

    Time frame: Baseline, Day 28

    Change in LDL-C level at Day 28 from baseline

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

    Time frame: Month 3, Month 12

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

  5. The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L

    Time frame: Day 28 , Month 12

    The proportion of patients who achieved the target LDL-C level of < 1.4 mmol/L at Day 28 and at 12 months

  6. The proportion of patients with progression and regression/no changes in atherosclerotic plaque

    Time frame: Baseline, Month 12

    The proportion of patients with progression and regression/no changes in atherosclerotic plaque determined on the basis of changes in its maximum height (mm) by carotid ultrasound at 12 months compared to 3-5 days after ACS (Acute Coronary Syndrome)

  7. Number (%) of patients who achieved the target LDL-C level of < 1.4 mmol/L and with change in the maximum plaque height (mm)

    Time frame: 12 months

    The correlation between the achievement of the target LDL-C level of < 1.4 mmol/L and a change in the maximum plaque height (mm) is going to be measured.

  8. Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE)

    Time frame: Month 3, Month 9, Month 12

    Total number of patients with adverse events (AE) in general, treatment-emergent AE (TEAEs), and serious adverse events (SAE) at 3, 9, and 12 months

  9. The number of patients who discontinued inclisiran therapy due to AEs

    Time frame: Month 3, Moth 9, Month 12

    The number of patients who discontinued inclisiran therapy due to AEs at 3, 9, and 12 months

  10. The number of patients re-hospitalized for CV events during the year

    Time frame: 12 months

    The number of patients re-hospitalized for cardiovascular (CV) events during the year

  11. The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization

    Time frame: 12 months

    The number of patients re-hospitalized during the year for scheduled and unscheduled revascularization

  12. Number of patients who sought emergency care after the baseline visit

    Time frame: 12 months

    Number of patients who sought emergency care after the baseline visit

  13. The number of patients placed under dispensary observation

    Time frame: 12 months

    The number of patients placed under dispensary observation

  14. Number of days from the date of hospital discharge to place under dispensary observation

    Time frame: 12 months

    Number of days from the date of hospital discharge to place under dispensary observation

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: STREAMLINE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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