Actively Recruiting

Phase 4
Age: 18Years - 100Years
All Genders
ID06501443

Latin America Lipid Optimization After Acute Event in Patients With Atherosclerotic Cardiovascular Disease and High LDL-C

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

520

Participants Needed

11

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the impact of adding inclisiran to usual care compared to usual care alone on lowering LDL cholesterol (LDL-C) in patients hospitalized after an acute cardiovascular event such as a heart attack, ischemic stroke, or urgent coronary revascularization. This multi-country, open-label, randomized clinical trial focuses on patients stabilized and ready for discharge following such events. The study explores the real-world effects on LDL-C levels, patient-reported outcomes, and healthcare resource use. Participants are divided into two groups: one receives usual care, which includes physical activity, diet changes, and standard cholesterol-lowering medications like statins and others; the other group receives the same usual care plus inclisiran injections at baseline, 90 days, and 270 days. Usual care treatments vary by country but commonly involve statins and other cholesterol-lowering drugs. This phase 4 study measures the effectiveness of inclisiran added to usual care over approximately 11 months. During the study, participants will have assessments at baseline and at day 330 to measure changes in LDL-C and other outcomes such as the proportion of patients achieving specific LDL-C reduction goals. Researchers also track the timing of statin initiation during the study period. Patient health, adherence to treatment, and safety will be monitored throughout. The study concludes for each participant after the last visit and related assessments at day 330.

CONDITIONS

Brief Title

LATAM LOWERS LDL-C

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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

You will not qualify if you...

  • Currently on PCSK9 inhibitor therapy within the last 3 months
  • Participating in another clinical study with a different study drug
  • Active liver disease including infectious, neoplastic, or metabolic liver conditions at baseline
  • Pregnant or nursing 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 11 months (330 days)

Participants receive usual care for lipid management after an acute cardiovascular event. Participants in the experimental group also receive inclisiran injections on Day 1, Day 90, and Day 270.

3 injection visits plus additional visits for usual care as per local guidelines

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

N

Novartis Pharmaceuticals

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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