NCT07142265Recruiting
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 19 Aug 2025
- Start date
- 30 Sept 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Coronary artery disease
- NCT number
- NCT07142265
What you commit to
- Study type: Observational
- Planned participants: 300
- From 30 Sept 2025 to the primary completion date, 30 Sept 2027
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Active inflammatory liver disease or the levels of AST, ALT \> 3 times, or total bilirubin \> 2 times higher than the upper limit of norm
Other
- Any other MACE in the anamnesis
Who the study is looking for
- 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)
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.