LATAM LOWERS LDL-C
NCT Number: NCT06501443
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hypercholesterolaemia
Interventions: DRUG: Usual care|DRUG: KJX839
Sponsor: Novartis Pharmaceuticals
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 520
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-29
Completion Date: 2026-11-29

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.

Primary Outcome Measures: Change in LDL-C from baseline to 330 days, Impact of inclisiran plus usual care on low-density lipoprotein cholesterol (LDL-C) lowering versus usual care after acute myocardial infarction (MI), confirmed ischemic stroke, or urgent coronary revascularization.

The "baseline" level will be measured according to:

* Baseline LDL-C from Standard of Care: If an LDL-C measurement has already been conducted as part of the standard care practices upon the patient's admission (prior to considering enrollment in the study), this measurement is considered the baseline value for the study.
* Baseline LDL-C for Enrolled Patients: In cases where LDL-C was not performed as part of standard care at admission, the baseline LDL-C measurement will be drawn during 'Visit 0' after the patient has provided informed consent., Baseline and Day 330
Secondary Outcome Measures: Proportion of patients with >=50% reduction in LDL-C from baseline., The "baseline" level will be measured according to:

* Baseline LDL-C from Standard of Care: If an LDL-C measurement has already been conducted as part of the standard care practices upon the patient's admission (prior to considering enrollment in the study), this measurement is considered the baseline value for the study.
* Baseline LDL-C for Enrolled Patients: In cases where LDL-C was not performed as part of standard care at admission, the baseline LDL-C measurement will be drawn during 'Visit 0' after the patient has provided informed consent., Baseline and Day 330|Proportion of patients achieving LDL-C goal of <70 mg/dL, Reducing LDL-C to a threshold of at least 70 mg/dL is a cornerstone of secondary prevention therapy, and is recommended by major international guidelines., 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, The "baseline" level will be measured according to:

* Baseline LDL-C from Standard of Care: If an LDL-C measurement has already been conducted as part of the standard care practices upon the patient's admission (prior to considering enrollment in the study), this measurement is considered the baseline value for the study.
* Baseline LDL-C for Enrolled Patients: In cases where LDL-C was not performed as part of standard care at admission, the baseline LDL-C measurement will be drawn during 'Visit 0' after the patient has provided informed consent., Baseline and Day 330|Number of participants by timing of statin initiation, Number of participants by statin initiated during index hospitalization vs. not., Up to 330 days