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LATAM LOWERS LDL-C

NCT06501443 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2025-12-30

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2026-11-27
Completion
2026-11-29

Countries

  • Argentina
  • Brazil

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06501443 on ClinicalTrials.gov