LATAM LOWERS LDL-C

Last updated: March 11, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

Hypercholesterolemia

Treatment

Usual care

KJX839

Clinical Study ID

NCT06501443
CKJX839A1MX02
  • Ages 18-100
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronaryrevascularization (PCI or CABG) or confirmed ischemic stroke.

  • Stable patient: Patient will be considered stable if they did not suffer cardiacarrest 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 toapproved local label.

  • Of note, patients who are initiated on statin therapy during the samehospitalization will not be excluded, as we expect a proportion of patients atbaseline to not yet be on statin therapy in this real-world study. This willenhance the generalizability and pragmatic aspects of the study. However,because initiation of statin therapy at or near the time of enrollment couldimpact the primary outcome (if there is imbalance between the arms, or if thereis differential stopping of statin therapy between the arms), we will stratifyrandomization by this factor and will pre-specify analyses in those who havevs. have not been initiated on statin therapy during the same hospitalization.

Exclusion

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, ormetabolic pathology of the liver at the Baseline Visit

  • Pregnant or nursing (lactating) women

  • Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraception

Study Design

Total Participants: 520
Treatment Group(s): 2
Primary Treatment: Usual care
Phase: 4
Study Start date:
February 11, 2025
Estimated Completion Date:
November 29, 2026

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Corrientes, W3400
    Argentina

    Active - Recruiting

  • Novartis Investigative Site

    Sao Jose, Sao Paulo 15015-110
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Campina Grande Do Sul, 83430 000
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Salvador, 40301-155
    Brazil

    Active - Recruiting

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