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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
520
Treatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines
Inclisiran in solution for subcutaneous injection on day 1, day 90, and day 270
Novartis Investigative Site
Corrientes, Argentina
RECRUITINGNovartis Investigative Site
Salvador, Estado de Bahia, Brazil
RECRUITINGChange 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.
Time frame: Baseline and Day 330
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.
Time frame: 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.
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
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.
Novartis Pharmaceuticals
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
RECRUITINGNovartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil
RECRUITINGNovartis Investigative Site
Campo Largo, Paraná, Brazil
RECRUITINGNovartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGNovartis Investigative Site
Blumenau, Santa Catarina, Brazil
WITHDRAWNNovartis Investigative Site
São José, Santa Catarina, Brazil
RECRUITINGNovartis Investigative Site
São José, São Paulo, Brazil
RECRUITINGNovartis Investigative Site
Campina Gde Do Sul, Brazil
RECRUITING...and 1 more locations
Time frame: Baseline and Day 330
Number of participants by timing of statin initiation
Number of participants by statin initiated during index hospitalization vs. not.
Time frame: Up to 330 days