Actively Recruiting
LATAM LOWERS LDL-C
Led by Novartis Pharmaceuticals · Updated on 2025-12-30
520
Participants Needed
11
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LATAM LOWERS LDL-C
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted for MI (Type 1 NSTEMI or STEMI), urgent (non-elective) coronary revascularization (PCI or CABG), or confirmed ischemic stroke
- Stable patient without cardiac arrest at presentation and no cardiogenic shock or need for invasive hemodynamic, inotropic, or vasopressor support in the last 24 hours before randomization
- Eligible to receive inclisiran according to approved local label
- Patients initiated on statin therapy during the same hospitalization are allowed
You will not qualify if you...
- Currently on PCSK9i therapy within the last 3 months
- Currently participating in another clinical study with another study drug
- Active liver disease, including known infectious, neoplastic, or metabolic liver pathology at baseline
- Pregnant or nursing (lactating) 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
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Withdrawn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
CONTACT
N
Novartis Pharmaceuticals
CONTACT
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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