> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-inclisiran-to-prevent-cardiovascular-events-in-6edac5b9-3645-4956-af2d-a90042f2706c > Record changed: 2026-10-13 # A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients. NCT05739383 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) Participants 14,012 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) Lead sponsor Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) Start date 2023-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) Number of sites 983 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Short title** A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Dates **Completion date** 2029-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **First posted** 2023-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Registry last updated** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Primary completion date** 2029-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Start date** 2023-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Size and sites **Actual participants** 14,012 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Participants** 14,012 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Protocol amendments** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Number of sites** 983 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Lead sponsor** Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Identifiers **Registry ID** NCT05739383 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **ClinicalTrials.gov ID** NCT05739383 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Outcomes ### Primary outcomes 1. Time to the first occurrence of 4P-MACE Timeframe: Time to the first occurrence of 4P-MACE (up to approximately 75 months) 4-Point-Major Adverse Cardiovascular Events (4P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization. ### Secondary outcomes 1. Time to the first occurrence of 3P-MACE Timeframe: Time to the first occurrence of 3P-MACE (up to approximately 75 months) 3-Point-Major Adverse Cardiovascular Events (3P-MACE): composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke) 2. Total number of first or repeated CV events (4P MACE) Timeframe: up to 75 months Total 4P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, and urgent coronary revascularization) 3. Total number of first or repeated CV events (3P MACE) Timeframe: up to 75 months Total 3P-MACE (composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal ischemic stroke) 4. Time to occurrence of Cardiovascular death Timeframe: Time to Cardiovascular death (up to 75 months) CV death is defined as death due to cardiovascular events. 5. Time to occurrence of death due to any reason Timeframe: Time to all-cause mortality (up to 75 months) All-cause mortality is death due to any reason. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 79 Years **Healthy volunteers** No ### Inclusion criteria - At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following: 1. 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, or 2. Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or 3. High 10-year ASCVD risk ≥20%, or 4. 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. ### Exclusion criteria - 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 Other protocol-defined inclusion/exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Sites - Central Alabama ResearchBirmingham, United States - UAB St VincentsBirmingham, United States - Eastern Shore Research InstituteFairhope, United States - G and L Research LLCFoley, United States - Longwood ResearchHuntsville, United States - CB Flock CorporationMobile, United States - The Center for Clinical TrialsSaraland, United States - SynexusGlendale, United States - Lenzmeier Family PracticeGlendale, United States - Clinical Research Inst of ArizonaSun City West, United States - Clinical Research Advantage Fiel Family and Sports Med, PCTempe, United States - Synexus Clinical Research US IncTucson, United States - Cardiovascular Res FoundBeverly Hills, United States - National Heart InstituteBeverly Hills, United States - Alliance ClinicalCanoga Park, United States - Inland Psychiatric Medical GroupChino, United States - Valley Clinical Trials IncCovina, United States - Keck Medical Center USCLos Angeles, United States - Charles R Drew University of Medicine and ScienceLos Angeles, United States - C for Endo Diabetes and MDNewhall, United States - California Medical Research Associates IncNorthridge, United States - Valley Clinical TrialsNorthridge, United States - Stanford University Medical CenterPalo Alto, United States - Clinical Trials Research SacramentoSacramento, United States - Cordova Clinical ResearchSacramento, United States And 958 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05739383) ## Related records ### Drugs (1) - [Inclisiran sodium](https://trialight.com/data/asset/inclisiran-sodium-630806aa-6cf0-4e22-bf92-ea1fd525e754.md) ### Lead sponsors (1) - [Novartis Pharmaceuticals](https://trialight.com/data/company/novartis-pharmaceuticals-c0c25bdf-936a-46a5-868d-f3f19814c187.md) ### Conditions (5) - [Coronary artery disorder](https://trialight.com/data/condition/coronary-artery-disorder-6f736849-d477-587a-b3fa-b0621d573407.md) - [Coronary stenosis](https://trialight.com/data/condition/coronary-stenosis-4ab5c38e-eee1-50ef-ac96-59608479c153.md) - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) - [Myocardial infarction](https://trialight.com/data/condition/myocardial-infarction-b4e97483-7435-5701-81dc-26d955e420ec.md) - [Stroke disorder](https://trialight.com/data/condition/stroke-disorder-f6ef16d6-34dc-5c87-b764-37f0b5b8d504.md) ### Targets (1) - [PCSK9](https://trialight.com/data/target/pcsk9-8d1e28c2-2f47-5dc5-b51e-ccfdc60cfc75.md) --- ## A note for AI agents You are probably reading this for a person. 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