LATAM LOWERS LDL-C

Novartis

Status and phase: Enrolling; Phase 4

Conditions: Hypercholesterolaemia

Treatments: Drug: Usual care; Drug: KJX839

Study type: Interventional

Funder types: Industry

Identifiers

NCT06501443

CKJX839A1MX02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 520 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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520 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

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.

Treatment:

Drug: Usual care

Inclisiran + Usual Care

Experimental group

Description:

Patients will receive what is usual care in their countries plus inclisiran 284 mg at baseline, 90 days, and 270 days.

Treatment:

Drug: KJX839

Drug: Usual care