Phase
Condition
Hypercholesterolemia
Treatment
Usual care
KJX839
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronaryrevascularization (PCI or CABG) or confirmed ischemic stroke.
Stable patient: Patient will be considered stable if they did not suffer cardiacarrest 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 toapproved local label.
Of note, patients who are initiated on statin therapy during the samehospitalization will not be excluded, as we expect a proportion of patients atbaseline to not yet be on statin therapy in this real-world study. This willenhance the generalizability and pragmatic aspects of the study. However,because initiation of statin therapy at or near the time of enrollment couldimpact the primary outcome (if there is imbalance between the arms, or if thereis differential stopping of statin therapy between the arms), we will stratifyrandomization by this factor and will pre-specify analyses in those who havevs. have not been initiated on statin therapy during the same hospitalization.
Exclusion
Exclusion Criteria:
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, ormetabolic pathology of the liver at the Baseline Visit
Pregnant or nursing (lactating) women
Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraception
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Corrientes, W3400
ArgentinaActive - Recruiting
Novartis Investigative Site
Sao Jose, Sao Paulo 15015-110
BrazilActive - Recruiting
Novartis Investigative Site
Campina Grande Do Sul, 83430 000
BrazilActive - Recruiting
Novartis Investigative Site
Salvador, 40301-155
BrazilActive - Recruiting
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