Evaluating the impact of inclisiran on lowering LDL cholesterol in patients after acute cardiovascular events
Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C
This study is testing if adding a new cholesterol-lowering medication called inclisiran to regular care can help people who have recently had a heart attack or stroke lower their LDL cholesterol levels better than just regular care alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 520 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 11 sites (Corrientes and 10 other locations) |
| Trial ID | NCT06501443 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized clinical trial aims to assess the effectiveness of inclisiran combined with usual care compared to usual care alone in reducing LDL cholesterol levels in patients who have experienced acute myocardial infarction, ischemic stroke, or urgent coronary revascularization. The study will involve multiple countries in Latin America and will focus on patient-reported outcomes and healthcare resource utilization. Participants will be monitored for 330 days post-enrollment to evaluate the long-term effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates include patients admitted for myocardial infarction, urgent coronary revascularization, or confirmed ischemic stroke who are stable and eligible for inclisiran treatment.
Not a fit: Patients who are not stable or have experienced cardiac arrest at presentation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly lower LDL cholesterol levels in patients recovering from acute cardiovascular events, potentially reducing the risk of future heart-related complications.
How similar studies have performed: Previous studies have shown promising results with similar approaches in LDL cholesterol management, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke. * Stable patient: Patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization: * Was not in cardiogenic shock. * Did not required invasive hemodynamic, inotropic or vasopressor support. * Participants are required to be eligible for receiving inclisiran in accordance to approved local label. * Of note, patients who are initiated on statin therapy during the same hospitalization will not be excluded, as we expect a proportion of patients at baseline to not yet be on statin therapy in this real-world study. This will enhance the generalizability and pragmatic aspects of the study. However, because initiation of statin therapy at or near the time of enrollment could impact the primary outcome (if there is imbalance between the arms, or if there is differential stopping of statin therapy between the arms), we will stratify randomization by this factor and will pre-specify analyses in those who have vs. have not been initiated on statin therapy during the same hospitalization. Exclusion Criteria: * Currently on PCSK9i therapy (within last 3 months) * Current participation in another clinical study with another study drug * Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit * Pregnant or nursing (lactating) women * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
Where this trial is running
Corrientes and 10 other locations
- Novartis Investigative Site — Corrientes, Argentina (Recruiting)
- Novartis Investigative Site — Salvador, Estado de Bahia, Brazil (Recruiting)
- Novartis Investigative Site — Belo Horizonte, Minas Gerais, Brazil (Recruiting)
- Novartis Investigative Site — Belo Horizonte, Minas Gerais, Brazil (Recruiting)
- Novartis Investigative Site — Campo Largo, Paraná, Brazil (Recruiting)
- Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
- Novartis Investigative Site — Blumenau, Santa Catarina, Brazil (Withdrawn)
- Novartis Investigative Site — São José, Santa Catarina, Brazil (Recruiting)
- Novartis Investigative Site — São José, São Paulo, Brazil (Recruiting)
- Novartis Investigative Site — Campina Gde Do Sul, Brazil (Recruiting)
- Novartis Investigative Site — Salvador, Brazil (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.