LATAM LOWERS LDL-C

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06501443
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hypercholesterolaemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

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
  • KJX839 — DRUG
    Inclisiran in solution for subcutaneous injection on day 1, day 90, and day 270

Study Details

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.

Key Dates

First listed
Jul 15, 2024
Start date
Feb 11, 2025
Status verified
Dec 2025
Primary completion
Nov 27, 2026
Completion
Nov 29, 2026

Study Design

Enrollment
520 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in LDL-C from baseline to 330 days [ Time Frame: Baseline and Day 330 ]

Central Contacts

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