LATAM LOWERS LDL-C

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.

Study Overview

• Status: Recruiting
• Conditions: Hypercholesterolaemia
• Intervention / Treatment: Drug: Usual care; Drug: KJX839

Detailed Description

The primary objective is to evaluate the impact of inclisiran plus usual care on LDL-C lowering versus usual care after acute MI, confirmed ischemic stroke, or urgent coronary revascularization.

The secondary objective is to compare the LDL-C reduction of both arms in target population.

Study completion for an individual participant is defined as when the participant finishes the last visit (day 330) and any assessments associated with that visit.

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Argentina
  • Corrientes, Argentina, W3400CDS
    • Recruiting
    • Novartis Investigative Site
• Brazil
  • Campina Gde Do Sul, Brazil, 83430 000
    • Recruiting
    • Novartis Investigative Site
  • Salvador, Brazil, 40323-010
    • Recruiting
    • Novartis Investigative Site
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40170-130
      • Recruiting
      • Novartis Investigative Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30000
      • Recruiting
      • Novartis Investigative Site
    • Belo Horizonte, Minas Gerais, Brazil, 30110-934
      • Recruiting
      • Novartis Investigative Site
  • Paraná
    • Campo Largo, Paraná, Brazil, 83606-177
      • Recruiting
      • Novartis Investigative Site
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
      • Recruiting
      • Novartis Investigative Site
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89010-500
      • Withdrawn
      • Novartis Investigative Site
    • São José, Santa Catarina, Brazil, 88103-901
      • Recruiting
      • Novartis Investigative Site
  • São Paulo
    • São José, São Paulo, Brazil, 15015-110
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; Patients will receive what is the usual care in their respective countries. Usual care includes physical activity, diet modification, pharmacological therapy as: statin therapy (rosuvastatin, atorvastatin, simvastatin, pravastatin, lovastatin, fluvastatin, pitavastatin), ezetimibe, cholestyramine or bempedoic acid.	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
Experimental: Inclisiran + Usual Care; Patients will receive what is usual care in their countries plus inclisiran 284 mg at baseline, 90 days, and 270 days.	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; Other Names: Inclisiran

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL-C from baseline to 330 days	Impact of inclisiran plus usual care on low-density lipoprotein cholesterol (LDL-C) lowering versus usual care after acute myocardial infarction (MI), confirmed ischemic stroke, or urgent coronary revascularization. The "baseline" level will be measured according to: Baseline LDL-C from Standard of Care: If an LDL-C measurement has already been conducted as part of the standard care practices upon the patient's admission (prior to considering enrollment in the study), this measurement is considered the baseline value for the study.; Baseline LDL-C for Enrolled Patients: In cases where LDL-C was not performed as part of standard care at admission, the baseline LDL-C measurement will be drawn during 'Visit 0' after the patient has provided informed consent.	Baseline and Day 330

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with >=50% reduction in LDL-C from baseline.	The "baseline" level will be measured according to: Baseline LDL-C from Standard of Care: If an LDL-C measurement has already been conducted as part of the standard care practices upon the patient's admission (prior to considering enrollment in the study), this measurement is considered the baseline value for the study.; Baseline LDL-C for Enrolled Patients: In cases where LDL-C was not performed as part of standard care at admission, the baseline LDL-C measurement will be drawn during 'Visit 0' after the patient has provided informed consent.	Baseline and Day 330
Proportion of patients achieving LDL-C goal of <70 mg/dL	Reducing LDL-C to a threshold of at least 70 mg/dL is a cornerstone of secondary prevention therapy, and is recommended by major international guidelines.	Baseline and Day 330
Among participants with a baseline LDL-C≥55 mg/dL: Proportion of patients achieving LDL-C goal of <55 mg/dL	The "baseline" level will be measured according to: Baseline LDL-C from Standard of Care: If an LDL-C measurement has already been conducted as part of the standard care practices upon the patient's admission (prior to considering enrollment in the study), this measurement is considered the baseline value for the study.; Baseline LDL-C for Enrolled Patients: In cases where LDL-C was not performed as part of standard care at admission, the baseline LDL-C measurement will be drawn during 'Visit 0' after the patient has provided informed consent.	Baseline and Day 330
Number of participants by timing of statin initiation	Number of participants by statin initiated during index hospitalization vs. not.	Up to 330 days

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2025
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): November 29, 2026

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: hypercholesterolemia; LDL-cholesterol; atherosclerotic cardiovascular disease; Latin America; PCSK9i
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Nutritional and Metabolic Diseases; Hypercholesterolemia; Atherosclerosis; ALN-PCS
• Other Study ID Numbers: CKJX839A1MX02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No