VESALIUS-CV

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

Official title

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

Phase

Phase 3

Status

Completed

Conditions

Coronary Heart Disease (CHD)

Interventions

Evolocumab; Placebo

Arms

• Placebo · Placebo comparator
• Evolocumab 140 mg Q2W · Experimental

Enrollment

12,301

Primary outcomes

• Number of Participants Who Experienced Coronary Heart Disease (CHD) Death, Myocardial Infarction (MI), or Ischemic Stroke, Whichever Occurred First
• Number of Participants Who Experienced CHD Death, MI, Ischemic Stroke, or Any Ischemia-driven Arterial Revascularization, Whichever Occurred First

Sponsor

Amgen

Start

Jun 11, 2019

Primary completion

Jul 25, 2025

Results posted

Yes

Registry record

NCT03872401 · updated Jun 25, 2026

• Bohula EA, Marston NA, Ruzza A, Murphy SA, De Ferrari GM, Diaz R, Leiter LA, Elliott-Davey M, Wang H, Bhatia AK, Giugliano RP, Sabatine MS. Rationale and design of the effect of evolocumab in patients at high cardiovascular risk without prior myocardial infarction or stroke (VESALIUS-CV) trial. Am Heart J. 2024 Mar;269:179-190. doi: 10.1016/j.ahj.2023.12.004. Epub 2023 Dec 29. PubMed 38160917
• Giugliano RP, Bohula EA, Bellavia A, De Ferrari GM, Leiter A, Nicolau JC, Bhatia AK, Murphy SA, Liu L, Wang H, Blaha V, Erglis A, Ferreira J, Goudev A, Jensen HK, Kiss RG, Montalescot G, Parkhomenko A, Sattar N, Sinnaeve P, Slapikas R, Paiva da Silva Lima G, Sabatine MS; VESALIUS-CV Investigators. Effects of Evolocumab on Mortality Outcomes in Patients Without Previous Myocardial Infarction or Stroke: A Prespecified Analysis of the VESALIUS-CV Randomized Clinical Trial. Circulation. 2026 Aug 31. doi: 10.1161/CIRCULATIONAHA.126.082436. Online ahead of print. PubMed 42670293
• Nicolau JC, Murphy SA, Giugliano RP, Leiter LA, De Ferrari GM, Park JG, Kuder J, Liu L, Wang H, Shastri-Kumar V, Averkov O, Blaha V, Dzupina A, Ferreira J, Kuusisto J, Lopez-Sendon J, Lorenzatti AJ, Nicholls S, Pella D, Slapikas R, Tokgozoglu L, Vinereanu D, Cyrille M, Sabatine MS, Bohula EA. Cumulative Benefit With Evolocumab in Patients With No Prior Myocardial Infarction or Stroke in the VESALIUS-CV Study. J Am Coll Cardiol. 2026 Aug 28:S0735-1097(26)07440-1. doi: 10.1016/j.jacc.2026.08.015. Online ahead of print. PubMed 42663360
• Monguillon V, Marston NA, Bohula EA, Park JG, Kuder JF, Murphy SA, De Ferrari GM, Leiter LA, Nicolau JC, Ebenbichler C, Sinnaeve P, Goudev A, Budaj A, Averkov O, Tokgozoglu L, Blankstein R, Vinereanu D, Giugliano RP, Sabatine MS, O'Donoghue ML. Lipoprotein(a) Levels, Risk of Cardiovascular Events, and Benefit of Evolocumab: Findings From the VESALIUS-CV Trial. Circulation. 2026 Jun 23;153(25):1960-1968. doi: 10.1161/CIRCULATIONAHA.126.080999. Epub 2026 May 25. PubMed 42183757
• Bergmark BA, Bohula EA, Marston NA, Park JG, Kuder JF, Murphy SA, De Ferrari G, Leiter LA, Nicolau JC, Averkov O, Charng MJ, Ebenbichler C, Erglis A, Gouni-Berthold I, Montalescot G, Nicholls SJ, Sigurdsson A, Sinnaeve PR, Slapikas R, Tsioufis K, Verma S, Viigimaa M, Bhatia A, Xin L, Walsh E, Ohman EM, Giugliano RP, Sabatine MS. Evolocumab in Patients With Prior Percutaneous Coronary Intervention and No Prior Myocardial Infarction: Results From the VESALIUS-CV Trial. Circulation. 2026 Jul 7;154(1):28-36. doi: 10.1161/CIRCULATIONAHA.126.080616. Epub 2026 May 19. PubMed 42153665
• Marston NA, Bohula EA, Bhatia AK, De Ferrari GM, Leiter LA, Nicolau JC, Park JG, Murphy SA, Walsh E, Liu L, Verma S, Sattar N, Nicholls SJ, Lopez-Sendon J, Gouni-Berthold I, Tokgozoglu L, Blankstein R, Cyrille M, da Silva Lima GP, Giugliano RP, Sabatine MS; VESALIUS-CV Investigators. Evolocumab to Reduce First Major Cardiovascular Events in Patients Without Known Significant Atherosclerosis and With Diabetes: Results From the VESALIUS-CV Trial. JAMA. 2026 Apr 28;335(16):1400-1407. doi: 10.1001/jama.2026.3277. PubMed 41903215
• Bohula EA, Marston NA, Bhatia AK, De Ferrari GM, Leiter LA, Nicolau JC, Park JG, Kuder JF, Murphy SA, Walsh E, Wang H, Blaha V, Budaj A, Cornel JH, Goudev A, Kiss RG, Lorenzatti AJ, Parkhomenko A, Cyrille M, Paiva da Silva Lima G, Ohman EM, Giugliano RP, Sabatine MS; VESALIUS-CV Investigators. Evolocumab in Patients without a Previous Myocardial Infarction or Stroke. N Engl J Med. 2026 Jan 8;394(2):117-127. doi: 10.1056/NEJMoa2514428. Epub 2025 Nov 8. PubMed 41211925