> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-inclisiran-to-prevent-cardiovascular-cv-events-in-e844a1d9-2336-4544-a1e8-7e5d7e3e378e > Record changed: 2026-10-13 # Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease NCT05030428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) Participants 17,004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) Lead sponsor Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) Start date 2021-11-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) Number of sites 983 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Acronym** VICTORION-2P Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Short title** Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Official title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## Dates **Completion date** 2027-05-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **First posted** 2021-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Registry last updated** 2026-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Primary completion date** 2027-05-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Start date** 2021-11-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## Size and sites **Actual participants** 17,004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Participants** 17,004 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Number of sites** 983 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Lead sponsor** Novartis Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## Identifiers **Registry ID** NCT05030428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **ClinicalTrials.gov ID** NCT05030428 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** Double-blind **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## Outcomes ### Primary outcomes 1. Time to First Occurrence of 3P-MACE (3-Point Major Adverse Cardiovascular Events) Timeframe: From randomization to total follow-up time (up to 72 months) 3P-MACE is a confirmed composite endpoint which includes cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke. ### Secondary outcomes 1. Time to Occurrence of Cardiovascular (CV) Death Timeframe: From randomization to total follow-up time (up to 72 months) CV death is defined as death due to cardiovascular events 2. Time to First Occurrence of 4P-MACE (4-Point Major Adverse Cardiovascular Events) Timeframe: From randomization to total follow-up time (up to 72 months) A composite 4P- MACE is defined as CV death, non-fatal MI, non-fatal ischemic stroke and urgent coronary revascularization. 3. Time to first occurrence of Major Limb Adverse Events (MALE) Timeframe: From randomization to total follow-up time (up to 72 months) Major Limb Adverse Events including acute lower limb ischemia, lower limb amputation due to ischemia, or urgent lower limb revascularization for ischemia 4. Time to occurrence of all-cause death Timeframe: From randomization to total follow-up time (up to 72 months) All-Cause death is defined as: all deaths from randomization until up to 72 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Maximum age** 100 Years **Healthy volunteers** No ### Inclusion criteria 1. Fasting LDL-C ≥ 70 mg/dL at randomization visit 2. 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 3. Established CV disease defined as ANY of the following three conditions 1. Spontaneous Myocardial infarction ≥ 4 weeks from screening visit 2. History of ischemic stroke occurred ≥ 4 weeks prior to the Screening visit 3. Symptomatic peripheral arterial disease (PAD) evidenced by either intermittent claudication with ankle brachial index (ABI) < 0.85, prior peripheral arterial revascularization procedure, or, amputation due to atherosclerotic disease. ### Exclusion criteria 1. Acute coronary syndrome, stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 4 weeks before screening visit 2. Treatment with PCSK9 inhibitors (e.g. evolocumab, alirocumab) within 90 days or planned use post first study visit 3. Planned or expected cardiac, cerebrovascular or peripheral artery surgery or re-vascularization within the 6 months after the first study visit 4. Heart failure NYHA class III or IV 5. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver 6. Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years 7. Severe concomitant non-CV disease that is expected to reduce life expectancy to less than 5 years 8. History of malignancy that required surgery radiation therapy and/or systemic therapy during the 3 years prior to the first study visit 9. Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## Sites - UAB St VincentsBirmingham, United States - Eastern Shore Research InstituteFairhope, United States - G and L Research LLCFoley, United States - Alaska Heart and VascularAnchorage, United States - Mercy Gilbert Medical CenterGilbert, United States - Cardiovascular Associates of MesaMesa, United States - Elite Clinical StudiesPhoenix, United States - HonorHealth Heart Group Deer ValleyScottsdale, United States - Clinical Research Inst of ArizonaSun City West, United States - Pima Heart And Vascular Clin RchTucson, United States - ARcare Center for Clinical ResearchLittle Rock, United States - Arkansas Clinical ResearchLittle Rock, United States - Central Cardiology Medical CenterBakersfield, United States - Alliance ClinicalCanoga Park, United States - Inland Psychiatric Medical GroupChino, United States - John Muir Physician Network Clinical Research CenterConcord, United States - TriallogixFullerton, United States - Diabetes Lipid Management CenterHuntington Beach, United States - University of Calif Irvine Med CntrIrvine, United States - UC San Diego HealthLa Jolla, United States - American Institute of ResearchLos Angeles, United States - Keck Medical Center USCLos Angeles, United States - University of California LALos Angeles, United States - VA Palo Alto Health Care SystemPalo Alto, United States - San Diego Veterans Medical CenterSan Diego, United States And 958 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## References - PubMed 42203164 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42203164/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05030428) ## 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 (3) - [Atherosclerosis](https://trialight.com/data/condition/atherosclerosis-5dab64e9-1fd4-5dd2-90c2-ce84935652d1.md) - [Atherosclerotic cardiovascular disease](https://trialight.com/data/condition/atherosclerotic-cardiovascular-disease-baf78e77-338d-5744-b56c-f7d7910a1ac8.md) Primary condition - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.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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