Early inclisiran after a heart attack: one-year outcomes
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
This project will test whether giving inclisiran within about two weeks after a STEMI or non‑STEMI improves cholesterol control and clinical outcomes over the first year in adults with recent MI and dyslipidemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 16 sites (Cheboksary and 15 other locations) |
| Trial ID | NCT07142265 on ClinicalTrials.gov |
What this trial studies
This observational, real‑world registry will follow adults in Russia who receive their first inclisiran injection within 14 ± 5 days after a STEMI or non‑STEMI and meet dyslipidemia LDL thresholds. Patients will be followed for 12 months to track changes in lipid profile, safety signals, carotid ultrasound measures of atherosclerotic plaque, hospitalizations, and need for intensified follow‑up. Key exclusions include prior PCSK9 inhibitor therapy, active inflammatory liver disease or markedly elevated liver tests, severe comorbid organ failure, and prior major adverse cardiovascular events. Data will reflect routine clinical care at participating Novartis investigational sites and describe outcomes in a post‑MI population receiving early inclisiran.
Who should consider this trial
Good fit: Adults of either sex with a recent STEMI or non‑STEMI, diagnosed dyslipidemia, and eligible for a first inclisiran injection within about two weeks who meet the listed LDL and laboratory criteria and can provide informed consent.
Not a fit: Patients with severe oncologic or end‑organ disease, active inflammatory liver disease or very high liver enzymes, prior PCSK9 inhibitor use, or other recent major cardiovascular events are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could lower LDL cholesterol early after MI and may reduce recurrent events and hospital readmissions over the first year.
How similar studies have performed: Large clinical programs of inclisiran have demonstrated substantial and sustained LDL‑C reductions in people with atherosclerotic disease, but robust long‑term post‑MI outcome data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cheboksary and 15 other locations
- Novartis Investigative Site — Cheboksary, Russia (Recruiting)
- Novartis Investigative Site — Grozny, Russia (Recruiting)
- Novartis Investigative Site — Kemerovo, Russia (Recruiting)
- Novartis Investigative Site — Khanty-Mansiysk, Russia (Recruiting)
- Novartis Investigative Site — Moscow, Russia (Recruiting)
- Novartis Investigative Site — Moscow, Russia (Recruiting)
- Novartis Investigative Site — Moscow, Russia (Recruiting)
- Novartis Investigative Site — Novosibirsk, Russia (Recruiting)
- Novartis Investigative Site — Penza, Russia (Recruiting)
- Novartis Investigative Site — Petrozavodsk, Russia (Recruiting)
- Novartis Investigative Site — Rostov-on-Don, Russia (Recruiting)
- Novartis Investigative Site — S Petersburg, Russia (Recruiting)
- Novartis Investigative Site — Samara, Russia (Recruiting)
- Novartis Investigative Site — Syktyvkar, Russia (Recruiting)
- Novartis Investigative Site — Tomsk, Russia (Recruiting)
- Novartis Investigative Site — Ulan-Ude, Russia (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.