NCT06501443

LATAM LOWERS LDL-C

Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Hypercholesterolaemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-11
• Primary completion: 2026-11-27
• Completion: 2026-11-29
• First posted: 2024-07-15
• Last updated: 2025-12-30

Locations

11 sites across 2 countries: Argentina, Brazil