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RECRUITINGPhase 4INTERVENTIONAL

LATAM LOWERS LDL-C

Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Usual care

Treatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines

DRUG

KJX839

Inclisiran in solution for subcutaneous injection on day 1, day 90, and day 270

Locations (11)

Novartis Investigative Site
Corrientes, Argentina
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
Novartis Investigative Site
Campo Largo, Paraná, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
Novartis Investigative Site
Blumenau, Santa Catarina, Brazil
Novartis Investigative Site
São José, Santa Catarina, Brazil
Novartis Investigative Site
São José, São Paulo, Brazil
Novartis Investigative Site
Campina Gde Do Sul, Brazil
Novartis Investigative Site
Salvador, Brazil