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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07142265
Status
Recruiting
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Conditions

  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 26, 2025
Start date
Sep 30, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: STEMI/Non-STEMI
    Patients with inclisiran initiation in 14 ± 5 days after STEMI/non-STEMI

Primary Outcome Measure

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 ]

Central Contacts

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