NCT07142265 Evaluation of 1-Year Clinical Outcomes With Early Inclisiran Initiation in Post-MI Patients
| NCT ID | NCT07142265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Myocardial Infarction |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-09-30 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07142265 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07142265 currently recruiting?
Yes, NCT07142265 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07142265 trial being conducted?
This trial is being conducted at Cheboksary, Russia, Grozny, Russia, Kaluga, Russia, Kemerovo, Russia and 11 additional locations.
Who is sponsoring the NCT07142265 clinical trial?
NCT07142265 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 300 participants.