LATAM LOWERS LDL-C

NCT06501443 | Recruiting Phase 4 DMC

• 1 other identifier: CKJX839A1MX02
• Study Type: interventional
• Target: 520
• Locations: 2 countries
• Sites: 11

Brief 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.

Conditions

Hypercholesterolaemia

Keywords

PCSK9i; hypercholesterolemia; atherosclerotic cardiovascular disease; LDL-cholesterol; Latin America

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of patients with >=50% reduction in LDL-C from baseline.

  Baseline and Day 330

• Proportion of patients achieving LDL-C goal of <70 mg/dL

  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

  Baseline and Day 330

• Number of participants by timing of statin initiation

  Up to 330 days

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Inclisiran + Usual Care

EXPERIMENTAL

Patients will receive what is usual care in their countries plus inclisiran 284 mg at baseline, 90 days, and 270 days.

Drug: Usual care; Drug: KJX839

Interventions

Usual care DRUG

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

Inclisiran + Usual Care; Usual Care

KJX839 DRUG

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

Also known as: Inclisiran

Inclisiran + Usual Care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

Novartis Investigative Site

Corrientes, W3400CDS, Argentina

RECRUITING

Novartis Investigative Site

Salvador, Estado de Bahia, 40170-130, Brazil

RECRUITING

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30000, Brazil

RECRUITING

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30110-934, Brazil

RECRUITING

Novartis Investigative Site

Campo Largo, Paraná, 83606-177, Brazil

RECRUITING

Novartis Investigative Site

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

RECRUITING

Novartis Investigative Site

Blumenau, Santa Catarina, 89010-500, Brazil

WITHDRAWN

Novartis Investigative Site

São José, Santa Catarina, 88103-901, Brazil

RECRUITING

Novartis Investigative Site

São José, São Paulo, 15015-110, Brazil

RECRUITING

Novartis Investigative Site

Campina Gde Do Sul, 83430 000, Brazil

RECRUITING

Novartis Investigative Site

Salvador, 40323-010, Brazil

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia; Atherosclerosis

Interventions

ALN-PCS

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 15, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): November 29, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

AR (1); BR (10)