Hypercholesterolaemia
Conditions
Keywords
PCSK9i, hypercholesterolemia, atherosclerotic cardiovascular disease, LDL-cholesterol, Latin America
Brief 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.
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
DRUGUsual care
Treatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines
DRUGKJX839
Inclisiran in solution for subcutaneous injection on day 1, day 90, and day 270
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL-C from baseline to 330 days | Baseline and Day 330 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with >=50% reduction in LDL-C from baseline. | Baseline and Day 330 | 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. |
| Proportion of patients achieving LDL-C goal of <70 mg/dL | Baseline and Day 330 | 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. |
| Among participants with a baseline LDL-C≥55 mg/dL: Proportion of patients achieving LDL-C goal of <55 mg/dL | Baseline and Day 330 | 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. |
| Number of participants by timing of statin initiation | Up to 330 days | Number of participants by statin initiated during index hospitalization vs. not. |
Countries
Argentina, Brazil
Contacts
Primary ContactNovartis Pharmaceuticals
Backup ContactNovartis Pharmaceuticals
Outcome results
None listed