LATAM LOWERS LDL-C
ConditionHypercholesterolaemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
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
This trial does not accept healthy volunteersQualifiers
Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke.
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Usual care
DrugTreatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines
KJX839
DrugInclisiran in solution for subcutaneous injection on day 1, day 90, and day 270
Treatment groups
520 Participants
are divided into 2 treatment groupsGroup A: Usual CareActive comparator 1 intervention
Group B: Inclisiran + Usual CareExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and Day 330Secondary outcomes
1
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 3302
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 3303
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.
Time frame
Baseline and Day 3304
Number of participants by timing of statin initiation
Number of participants by statin initiated during index hospitalization vs. not.
Time frame
Up to 330 daysSponsors and contacts
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Source ClinicalTrials.gov