Last updated 7 months ago

LATAM LOWERS LDL-C

520 patients around the world

Available in Brazil, Argentina

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.

Novartis Pharmaceuticals

520Patients around the world

This study is for people with

Hypercholesterolemia

Requirements for the patient

To 100 Years

All Gender

Medical requirements

: 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 require 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, 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.

: 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.

SponsorNovartis Pharmaceuticals

Study typeInterventional

Conditions

Hypercholesterolemia

Requirements

To 100 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06501443