Status:
RECRUITING
LATAM LOWERS LDL-C
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hypercholesterolaemia
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
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, pati...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 29 2026
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT06501443
Start Date
February 11 2025
End Date
November 29 2026
Last Update
December 30 2025
Active Locations (11)
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1
Novartis Investigative Site
Corrientes, Argentina, W3400CDS
2
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 40170-130
3
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30000
4
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil, 30110-934