A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)
A Randomized, Double-blind, Placebo-controlled, Multicenter Trial, Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Participants With Established Cardiovascular Disease (VICTORION-2 PREVENT)
Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).
Purpose of this study is to test the hypothesis that treatment with inclisiran sodium 300 mg s.c. administered on Day 1, Month 3 (Day 90), and every 6 months thereafter taken in addition to well-tolerated high-intensity statin therapy in participants with established ASCVD will significantly reduce the risk of 3-Point-Major Adverse Cardiovascular Events (3P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI) and non-fatal ischemic stroke. This will be compared to placebo in adjunct to well-tolerated high-intensity statin therapy.
Inclusion Criteria:
Fasting LDL-C ≥ 70 mg/dL at randomization visit
Stable (greater than or equal to 4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin greater than or equal to 40 mg QD or rosuvastatin greater than or equal to 20 mg QD
Established CV disease defined as ANY of the following three conditions
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
CABA, Buenos Aires C1056ABI, Argentina
Caba, Buenos Aires C1119ACN, Argentina
CABA, Buenos Aires C1187AAN, Argentina
CABA, Buenos Aires C1221ADC, Argentina
CABA, Buenos Aires C1280AEB, Argentina
CABA, Buenos Aires C1405BCH, Argentina
CABA, Buenos Aires C1426ABP, Argentina
San Miguel Tucuman, Tucumán Province T4000IFL, Argentina
Caba, C1427CCL, Argentina
Sao Jose Rio Preto, São Paulo 15015-750, Brazil
Sao Jose Rio Preto, São Paulo 15090-000, Brazil
Longueuil, British Columbia J4H 4B9, Canada
Stoufville, Ontario L4A 1H2, Canada
Xian, Shanxi 710061, China
Oroshaza, Csongrád megye 5900, Hungary
Budapest, Pest County 1134, Hungary
Hyderabad, Andhra Pradesh 500033, India
Uttarakhand, 263153, India
Sefad, 1311300, Israel
Kuala Lumpur, Selangor 43000, Malaysia
Solferino Phoenix, Mauritius 1772, Mauritius
Nordbyhagen, Oslo 1478, Norway
Ostrowiec Swietok, 27-400, Poland
Bundang Gu, Gyeonggi-do 13620, South Korea
Santiago Compostela, A Coruna 15706, Spain
Mallorca, Balearic Islands 07198, Spain
San Sebastian Reyes, Madrid 28702, Spain
Las Palmas GC, 35010, Spain
Muang, Thailand 12120, Thailand
Muang, 40002, Thailand