Clinical trial NCT06501443: LATAM LOWERS LDL-C
Official title: Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hypercholesterolaemia
Keywords: PCSK9i
hypercholesterolemia
atherosclerotic cardiovascular disease
LDL-cholesterol
Latin America
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in LDL-C from baseline to 330 days
timeFrame: Baseline and Day 330
Secondary outcomes:
measure: Proportion of patients with >=50% reduction in LDL-C from baseline.
timeFrame: Baseline and Day 330
measure: Proportion of patients achieving LDL-C goal of <70 mg/dL
timeFrame: Baseline and Day 330
measure: Among participants with a baseline LDL-C≥55 mg/dL: Proportion of patients achieving LDL-C goal of <55 mg/dL
timeFrame: Baseline and Day 330
measure: Number of participants by timing of statin initiation
timeFrame: Up to 330 days
Other outcomes:
Locations:
city: Corrientes
country: Argentina
facility: Novartis Investigative Site
city: Sao Jose
country: Brazil
facility: Novartis Investigative Site
state: Sao Paulo
city: Campina Grande Do Sul
country: Brazil
facility: Novartis Investigative Site
city: Salvador
country: Brazil
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: