LATAM LOWERS LDL-C

Official title

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

Overview

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.

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

Primary outcome measures

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

Secondary outcome measures (4)

• Proportion of patients with >=50% reduction in LDL-C from baseline. [Time frame: Baseline and Day 330]
• Proportion of patients achieving LDL-C goal of <70 mg/dL [Time frame: 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 [Time frame: Baseline and Day 330]
• Number of participants by timing of statin initiation [Time frame: Up to 330 days]

Eligibility criteria

Inclusion criteria

• 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.

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, 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 10 centers

• Novartis Investigative Site — Salvador
• Novartis Investigative Site — Belo Horizonte
• Novartis Investigative Site — Belo Horizonte
• Novartis Investigative Site — Campo Largo
• Novartis Investigative Site — Porto Alegre
• Novartis Investigative Site — Blumenau
• Novartis Investigative Site — São José
• Novartis Investigative Site — São José
• … and 2 more centers

Argentina · 1 center

• Novartis Investigative Site — Corrientes

Identifiers

NCT: NCT06501443 · CKJX839A1MX02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗