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

Last updated: April 13, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Circulation Disorders

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT07142265
CKJX839D1RU01
  • Ages 18-100
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Adult patients of both genders

  • Myocardial Infarction diagnosis

  • Dyslipidemia diagnosis

  • The first injection of inclisiran no later than 14 ± 5 days after theSTEMI/non-STEMI

  • LDL-C > 5 mmol/L (statin-naive patients) or LDL-C > 2.5 mmol/L (on the basis ofstatin MTD) at the time of hospitalization or no target LDL-C level (> 1.4 mmol/L orno LDL-C level decrease by 50% on statin MTD + ezetimibe)

  • Signed Informed Consent Form (ICF)

Exclusion

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 totalbilirubin > 2 times higher than the upper limit of norm

  • Any other MACE in the anamnesis

Study Design

Total Participants: 300
Study Start date:
September 30, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Novartis Investigative Site

    Cheboksary, 428000
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Cheboksary 569696, 428000
    Russia

    Site Not Available

  • Novartis Investigative Site

    Grozny, 364051
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Kemerovo, 650002
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Kemerovo 1503901, 650002
    Russia

    Site Not Available

  • Novartis Investigative Site

    Moscow, 105203
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Moscow 524901, 105203
    Russia

    Site Not Available

  • Novartis Investigative Site

    Novosibirsk, 630051
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Novosibirsk 1496747, 630051
    Russia

    Site Not Available

  • Novartis Investigative Site

    Penza, 440026
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Petrozavodsk, 185019
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Petrozavodsk 509820, 185019
    Russia

    Site Not Available

  • Novartis Investigative Site

    Rostov-on-Don, 344010
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Rostov-on-Don 501175, 344010
    Russia

    Site Not Available

  • Novartis Investigative Site

    S Petersburg, 192242
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Syktyvkar, 167981
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Tomsk, 634009
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Ulan-Ude, 670031
    Russia

    Active - Recruiting

  • Novartis Investigative Site

    Ulan-Ude 2014407, 670031
    Russia

    Site Not Available

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