NCT06501443RecruitingPhase 4
LATAM LOWERS LDL-C
Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 520 (estimated)
- First submitted
- 21 Jun 2024
- Start date
- 11 Feb 2025
- Primary completion date
- 27 Nov 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06501443
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 520
- From 11 Feb 2025 to the primary completion date, 27 Nov 2026
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on PCSK9i therapy (within last 3 months)
- Current participation in another clinical study with another study drug
Other illness
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Corrientes | Argentina | Recruiting |
| - Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Blumenau | Brazil | Withdrawn |
| - Coordinator of this site? Confirm its status | Campina Gde Do Sul | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Campo Largo | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| - Coordinator of this site? Confirm its status | São José | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.