Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

Summary

This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.

Timeline

Start

2019-06-11

Primary completion

2025-07-25

Completion

2025-07-25

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo Q2W vs Evolocumab 140 mg Q2W; p < 0.001; Hazard Ratio (HR) 0.75 (95% CI 0.65 to 0.86); Log Rank NCT03872401 ↗

registry analysis (superiority test); Placebo Q2W vs Evolocumab 140 mg Q2W; p < 0.001; Hazard Ratio (HR) 0.81 (95% CI 0.73 to 0.89); Log Rank NCT03872401 ↗

release “the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating that Repatha ® (evolocumab) significantly reduced the risk” amgen.com ↗

release “from the Phase 3 VESALIUS-CV clinical trial. Results showed Repatha reduced the risk of the composite primary endpoint” amgen.com ↗

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evolocumab	Monoclonal antibody	140 mg	Subcutaneous

Indications