Actively Recruiting

Phase 4
Age: 18Years - 100Years
All Genders
NCT06501443

LATAM LOWERS LDL-C

Led by Novartis Pharmaceuticals · Updated on 2025-12-30

520

Participants Needed

11

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

LATAM LOWERS LDL-C

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted for MI (Type 1 NSTEMI or STEMI), urgent (non-elective) coronary revascularization (PCI or CABG), or confirmed ischemic stroke
  • Stable patient without cardiac arrest at presentation and no cardiogenic shock or need for invasive hemodynamic, inotropic, or vasopressor support in the last 24 hours before randomization
  • Eligible to receive inclisiran according to approved local label
  • Patients initiated on statin therapy during the same hospitalization are allowed
Not Eligible

You will not qualify if you...

  • Currently on PCSK9i therapy within the last 3 months
  • Currently participating in another clinical study with another study drug
  • Active liver disease, including known infectious, neoplastic, or metabolic liver pathology at baseline
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential not using highly effective contraception

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Novartis Investigative Site

Corrientes, Argentina, W3400CDS

Actively Recruiting

2

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil, 40170-130

Actively Recruiting

3

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil, 30000

Actively Recruiting

4

Novartis Investigative Site

Belo Horizonte, Minas Gerais, Brazil, 30110-934

Actively Recruiting

5

Novartis Investigative Site

Campo Largo, Paraná, Brazil, 83606-177

Actively Recruiting

6

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil, 90560-032

Actively Recruiting

7

Novartis Investigative Site

Blumenau, Santa Catarina, Brazil, 89010-500

Withdrawn

8

Novartis Investigative Site

São José, Santa Catarina, Brazil, 88103-901

Actively Recruiting

9

Novartis Investigative Site

São José, São Paulo, Brazil, 15015-110

Actively Recruiting

10

Novartis Investigative Site

Campina Gde Do Sul, Brazil, 83430 000

Actively Recruiting

11

Novartis Investigative Site

Salvador, Brazil, 40323-010

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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LATAM LOWERS LDL-C | DecenTrialz