LATAM LOWERS LDL-C

Launched by NOVARTIS PHARMACEUTICALS · Jul 8, 2024

Keywords

ClinConnect Summary

The LATAM LOWERS LDL-C clinical trial is studying the effects of a medication called inclisiran, combined with usual care, on lowering cholesterol levels in patients who have experienced serious heart issues, like a heart attack or stroke. This trial is specifically looking at how this treatment works in real-life hospital settings, focusing on patients who are stable and ready to be discharged. Researchers want to understand not only how well inclisiran lowers cholesterol but also how it affects patients' quality of life and their use of healthcare services.

To be eligible for this trial, participants need to have been admitted to the hospital for a heart attack, a related procedure, or a stroke, and they must be stable enough for discharge. Patients who are currently on certain cholesterol medications or involved in other studies may not qualify. If you or a loved one meet these criteria and agree to join, you'll receive either the inclisiran treatment or usual care, and you will be monitored to see how well it helps lower cholesterol levels and improves your overall health. This study is important as it aims to provide real-world evidence on the benefits of inclisiran for patients after serious heart events.

Gender

ALL

Eligibility 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