Actively Recruiting
Latin America Lipid Optimization After Acute Event in Patients With Atherosclerotic Cardiovascular Disease and High LDL-C
Led by Novartis Pharmaceuticals · Updated on 2025-12-30
520
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the impact of adding inclisiran to usual care compared to usual care alone on lowering LDL cholesterol (LDL-C) in patients hospitalized after an acute cardiovascular event such as a heart attack, ischemic stroke, or urgent coronary revascularization. This multi-country, open-label, randomized clinical trial focuses on patients stabilized and ready for discharge following such events. The study explores the real-world effects on LDL-C levels, patient-reported outcomes, and healthcare resource use. Participants are divided into two groups: one receives usual care, which includes physical activity, diet changes, and standard cholesterol-lowering medications like statins and others; the other group receives the same usual care plus inclisiran injections at baseline, 90 days, and 270 days. Usual care treatments vary by country but commonly involve statins and other cholesterol-lowering drugs. This phase 4 study measures the effectiveness of inclisiran added to usual care over approximately 11 months. During the study, participants will have assessments at baseline and at day 330 to measure changes in LDL-C and other outcomes such as the proportion of patients achieving specific LDL-C reduction goals. Researchers also track the timing of statin initiation during the study period. Patient health, adherence to treatment, and safety will be monitored throughout. The study concludes for each participant after the last visit and related assessments at day 330.
CONDITIONS
Brief Title
LATAM LOWERS LDL-C
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted for heart attack (Type 1 NSTEMI or STEMI), urgent coronary revascularization (PCI or CABG), or confirmed ischemic stroke
- Stable patient without cardiac arrest at presentation and no cardiogenic shock or invasive hemodynamic, inotropic, or vasopressor support within 24 hours before randomization
- Eligible to receive inclisiran according to approved local label
- Patients starting statin therapy during the same hospitalization are allowed
You will not qualify if you...
- Currently on PCSK9 inhibitor therapy within the last 3 months
- Participating in another clinical study with a different study drug
- Active liver disease including infectious, neoplastic, or metabolic liver conditions at baseline
- Pregnant or nursing women
- Women of child-bearing potential not using highly effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 11 months (330 days)
Participants receive usual care for lipid management after an acute cardiovascular event. Participants in the experimental group also receive inclisiran injections on Day 1, Day 90, and Day 270.
3 injection visits plus additional visits for usual care as per local guidelines
Trial Site Locations
Total: 11 locations
1
Novartis Investigative Site
Corrientes, Argentina, W3400CDS
Actively Recruiting
2
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 40170-130
Actively Recruiting
3
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30000
Actively Recruiting
4
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30110-934
Actively Recruiting
5
Novartis Investigative Site
Campo Largo, Paraná, Brazil, 83606-177
Actively Recruiting
6
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
Actively Recruiting
7
Novartis Investigative Site
Blumenau, Santa Catarina, Brazil, 89010-500
Withdrawn
8
Novartis Investigative Site
São José, Santa Catarina, Brazil, 88103-901
Actively Recruiting
9
Novartis Investigative Site
São José, São Paulo, Brazil, 15015-110
Actively Recruiting
10
Novartis Investigative Site
Campina Gde Do Sul, Brazil, 83430 000
Actively Recruiting
11
Novartis Investigative Site
Salvador, Brazil, 40323-010
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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