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RECRUITING
NCT06501443
PHASE4

LATAM LOWERS LDL-C

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

520

Start Date

2025-02-11

Completion Date

2026-11-29

Last Updated

2025-12-30

Healthy Volunteers

No

Interventions

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