A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT)
A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTORION-1 PREVENT)
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
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.
Inclusion Criteria:
At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
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.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Sugarland, Texas 77478, United States
CABA, Buenos Aires 1425, Argentina
Caba, Buenos Aires C1119ACN, Argentina
CABA, Buenos Aires C1221ADC, Argentina
CABA, Buenos Aires C1280AEB, Argentina
CABA, Buenos Aires C1405BCH, Argentina
CABA, Buenos Aires C1406BOA, Argentina
CABA, Buenos Aires C1407FWE, Argentina
CABA, Buenos Aires C1414AIF, Argentina
CABA, Buenos Aires C1425AGC, Argentina
CABA, Buenos Aires C1426ABP, Argentina
Concepcion Uruguay, Entre Ríos Province 3260, Argentina
Grandero Baigorria, Santa Fe Province S2152, Argentina
San Miguel Tucuman, Tucumán Province T4000IFL, Argentina
Caba, C1015ABO, Argentina
Caba, C1427CCL, Argentina
Capital Federal, C1023AAB, Argentina
Sao Jose Rio Preto, São Paulo 15090 000, Brazil
Napean, Ontario K2J 0V2, Canada
North York, Ontario M6B 3H7, Canada
Xian, Shanxi 710061, China
Plzen Bory, 301 00, Czechia
Copenhagen S, 2300, Denmark
Kobenhavn N V, 2400, Denmark
Heraklion Crete., 715 00, Greece
Hong Kong SAR, 999077, Hong Kong
Budapest, Pest County 1132, Hungary
Mosanmagyarovar, 9200, Hungary
Uttarakhand, 263153, India
Sefad, 1311300, Israel
Timur Laut, Pulau Pinang 11500, Malaysia
Mexico D F, 06720, Mexico
Bygdoszcz, 85-605, Poland
Western Cape, 7130, South Africa
Santiago Compostela, A Coruna 15706, Spain
Mallorca, Balearic Islands 07198, Spain
Sanlucar Barrameda, Cadiz 11540, Spain
Las Palmas de Gran C, Las Palmas 35016, Spain
Las Palmas GC, 35010, Spain
Muang, Thailand 12120, Thailand
Denbighshire, LL18 1DA, United Kingdom
Lancashire, FY4 3AD, United Kingdom
Tyne and Wear, NE29 8NH, United Kingdom
Wiltshire, SN15 2SB, United Kingdom
Wirrel, CH62 6EE, United Kingdom