Tests KJX839 with usual care to lower LDL cholesterol after heart events
Tests KJX839 added to usual care in adults with high cholesterol after a heart event.
Plain-language title generated from the registry record
Registry title: LATAM LOWERS LDL-C
Key facts
- Where
- Belo Horizonte, Blumenau, Campina Gde Do Sul, Campo Largo, Porto Alegre, Salvador, and São José, BrazilSee the 7 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT06501443, who can take part
Where in Brazil
- Belo HorizonteBelo Horizonte, BrazilTaking people
- BlumenauBlumenau, BrazilNo longer taking part
- Campina Gde Do SulCampina Gde Do Sul, BrazilTaking people
- Campo LargoCampo Largo, BrazilTaking people
- Porto AlegrePorto Alegre, BrazilTaking people
- SalvadorSalvador, BrazilTaking people
- São JoséSão José, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06501443
- Record updated
- 30 December 2025
- Original description
This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.Read full original descriptionShow less
Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C
This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.
Inclusion: 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: 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.