Rationale and design of the effect of evolocumab in patients at high cardiovascular risk without prior myocardial infarction or stroke (VESALIUS-CV) trial
Study context
- Population
- Patients with atherosclerosis or high-risk DM without prior myocardial infarction (MI) or stroke; Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL, or non-HDL-C ≥ 120 mg/dL, or apolipoprotein B ≥ 80 mg/dL; on optimized lipid-lowering therapyrandomized 1:1
- Participants
- 12,301 patients
- Planned comparison
- Evolocumab vs placebo
- Primary endpoint
- Dual primary composites: Coronary heart disease (CHD) death, MI or ischemic stroke (triple); CHD death, MI, ischemic stroke or ischemia-driven arterial revascularization (quadruple)
Methodological detailsrationale and design, double-blind, placebo-controlled, global, Recruitment June 2019 to November 2021, Planned to continue until ≥751 triple and ≥1254 quadruple adjudicated endpoints and median follow-up ≥4.5 years
- Rationale and design
- Double-blind
- Placebo-controlled
- Global
- Recruitment June 2019 to November 2021
- Planned to continue until ≥751 triple and ≥1254 quadruple adjudicated endpoints and median follow-up ≥4.5 years
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
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. Published 29 December 2023. doi:10.
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