Last updated 4 months ago
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
14000 patients around the world
Available in United States, Argentina
The purpose of this study is to evaluate inclisiran sodium 300 mg s.c. (equivalent to 284
mg inclisiran) compared to placebo on reducing the risk of 4P-MACE in adult patients at
high risk for their first major adverse cardiovascular event.
Randomized participants will receive study medication (inclisiran or placebo),
administered s.c. on Day 1, Day 90, then every 6 months thereafter. This is an
event-driven study. Therefore, the study will continue until the required number of
clinical events have occurred across both treatment arms, and all participants have a
minimum of 3 years of follow-up during the double-blind treatment period.
Novartis Pharmaceuticals
1Research sites
14000Patients around the world
This study is for people with
Cardiovascular disease
Established cardiovascular disease
Requirements for the patient
To 79 Years
All Gender
Medical requirements
- At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but <50% in the left main coronary artery or stenosis ≥20% but <70% in any other major epicardial coronary artery,coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units,high 10-year ASCVD risk ≥20%,intermediate 10-year ASCVD risk 7.5% - <20% with at least 2 risk-enhancing factors.LDL-C ≥70 mg/dL (≥1.81 mmol/L) but <190 mg/dL (<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.
- History of major ASCVD event.History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization.Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization.Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization.Active liver disease or hepatic dysfunction.Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab).Pregnant or nursing (lactating) women.Women of childbearing potential unless they are using effective methods of contraception while taking study treatment which includes for 6 months after last study drug administration.
Sites
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
StudyVICTORION 1
SponsorNovartis Pharmaceuticals
Conditions
Established cardiovascular disease
Requirements
To 79 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05739383
