Status:
RECRUITING
Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-100 years
Brief 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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07142265
Start Date
September 30 2025
End Date
March 31 2027
Last Update
January 2 2026
Active Locations (7)
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1
Novartis Investigative Site
Cheboksary, Russia, 428000
2
Novartis Investigative Site
Kemerovo, Russia, 650002
3
Novartis Investigative Site
Moscow, Russia, 105203
4
Novartis Investigative Site
Novosibirsk, Russia, 630051