{
  "abstract": "RATIONALE: Inclisiran is a small interfering ribonucleic acid targeting hepatic proprotein convertase subtilisin/kexin type 9 messenger RNA, that effectively reduces low-density lipoprotein cholesterol (LDL-C) levels. The effect of inclisiran on cardiovascular (CV) outcomes has not been formally tested. METHODS: VICTORION-2 Prevent (NCT05030428) is an ongoing, Phase 3 randomized, double-blind, placebo-controlled, international trial assessing the efficacy and safety of inclisiran in preventing CV events in patients with established atherosclerotic cardiovascular disease (ASCVD) receiving high-intensity statin therapy. Patients with established ASCVD (history of myocardial infarction [MI], ischemic stroke, or symptomatic peripheral artery disease), and fasting plasma LDL-C ≥ 1.8 mmol/L (70 mg/dL) despite high-intensity statin therapy (≥ 20 mg rosuvastatin or ≥ 40 mg atorvastatin daily) will be enrolled. Patients will be treated with inclisiran sodium 300 mg or placebo, administered subcutaneously at Day 1, Day 90, and every 6 months thereafter. The primary outcome will include time to first occurrence of 3-point major adverse CV events (3P-MACE; composite of CV death, MI, or ischemic stroke). Secondary outcomes will include time to occurrence of CV death, time to first occurrence of 4P-MACE (composite of 3P-MACE and urgent revascularization), and major adverse limb event (all adjudicated outcomes), time to occurrence of all-cause death, and long-term safety of inclisiran. Safety will be monitored using a selective safety data collection strategy. CONCLUSION: VICTORION-2 Prevent will provide robust data on CV benefits and safety of inclisiran in patients with established ASCVD and not at guideline-recommended LDL-C goals despite high-intensity statin treatment. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT05030428.",
  "abstract_shown": true,
  "affiliations": [
    "Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université Paris-Cité, Paris, France; Department of Cardiology, French Alliance for Cardiovascular Trials (FACT)/F-CRIN, Paris, France. Electronic address: gabriel.steg@aphp.fr",
    "Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada; Unity Health Toronto, and Peter Munk Cardiac Centre, St. Michael's Hospital, University Health Network, University of Toronto, Toronto, ON, Canada",
    "Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands; Department of Cardiology, Netherlands Heart Institute, Utrecht, the Netherlands",
    "Department of Cardiology, Ziekenhuis Oost-Limburg A.V., Genk, Belgium; Faculty of Medicine and Life Science, Hasselt University, Diepenbeek, Belgium",
    "University Heart Center Graz, Medical University of Graz, Graz, Austria",
    "Icahn School of Medicine at Mount Sinai, Mount Sinai Fuster Heart Hospital, New York, NY",
    "Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH",
    "Icahn School of Medicine at Mount Sinai, Mount Sinai Fuster Heart Hospital, New York, NY; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; CPC Clinical Research, Aurora, CO; State University of New York, Downstate Health Sciences University, Brooklyn, NY",
    "Novartis Pharma AG, Basel, Switzerland",
    "Novartis Pharma AG, Basel, Switzerland; Department of Cardiology and Angiology, Faculty of Medicine, University Heart Center Freiburg-Bad Krozingen, Medical Center-University of Freiburg, University of Freiburg, Freiburg im Breisgau, Germany",
    "Novartis Pharma AG, CH-4056 Basel, Switzerland",
    "Icahn School of Medicine at Mount Sinai, The Zena and Michael A. Weiner Cardiovascular Institute, New York, NY"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 15,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Philippe Gabríel Steg",
      "orcid": "0000-0001-6896-2941"
    },
    {
      "affs": [
        1
      ],
      "name": "Shaun G. Goodman",
      "orcid": "0000-0001-8068-2440"
    },
    {
      "affs": [
        2
      ],
      "name": "J. Wouter Jukema",
      "orcid": "0000-0002-3246-8359"
    },
    {
      "affs": [
        3
      ],
      "name": "Pieter Martens",
      "orcid": "0000-0002-6036-2113"
    },
    {
      "affs": [
        4
      ],
      "name": "Andreas Zirlik",
      "orcid": "0000-0001-6290-3297"
    },
    {
      "affs": [
        5
      ],
      "name": "Deepak L. Bhatt",
      "orcid": "0000-0002-1278-6245"
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    {
      "affs": [
        6
      ],
      "name": "Venu Menon",
      "orcid": "0000-0003-4410-2677"
    },
    {
      "affs": [
        7
      ],
      "name": "Michael J. Szarek",
      "orcid": "0000-0002-0046-0264"
    },
    {
      "affs": [
        8
      ],
      "name": "Anastasia Lesogor"
    },
    {
      "affs": [
        9
      ],
      "name": "Christian Stratz",
      "orcid": "0000-0003-2716-688X"
    },
    {
      "affs": [
        10
      ],
      "name": "Fintan O’Donoghue"
    },
    {
      "affs": [
        8
      ],
      "name": "Jorge Alberto Mena-Madrazo",
      "orcid": "0000-0002-9759-708X"
    },
    {
      "affs": [
        8
      ],
      "name": "Qing Shao"
    },
    {
      "affs": [
        8
      ],
      "name": "Karen Liu"
    },
    {
      "affs": [
        11
      ],
      "name": "Roxana Mehran",
      "orcid": "0000-0002-5546-262X"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/5ame508h1kz68.bib",
  "cited_by": 15,
  "doi": "10.1016/j.ahj.2026.107493",
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  "id": "5ame508h1kz68",
  "issns": [
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    "1097-6744"
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  "landing_url": "https://doi.org/10.1016/j.ahj.2026.107493",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
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  "pmcid": null,
  "pmid": "42203164",
  "published": "2026-05-26",
  "publisher": "Elsevier BV",
  "ris": "https://research.draconitic.com/paper/5ame508h1kz68.ris",
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  "title": "Design of VICTORION-2 Prevent: A randomized double-blind, placebo-controlled trial, assessing the impact of inclisiran on major adverse cardiovascular events in patients with established cardiovascular disease",
  "title_text": "Design of VICTORION-2 Prevent: A randomized double-blind, placebo-controlled trial, assessing the impact of inclisiran on major adverse cardiovascular events in patients with established cardiovascular disease",
  "type": "peer-reviewed",
  "updated_at": "2026-11-15T13:21:07Z",
  "url": "https://research.draconitic.com/paper/5ame508h1kz68",
  "venue": "American Heart Journal",
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}